703-844-0184 | NOVA Health Ketamine Treatment Center Fairfax, Virginia 22201 | Peptide therapies |

What are peptides? Peptides are molecules that consist of between two to fifty amino acid sequence. The first commercial peptide therapy used was insulin (1923).

What are peptide therapies? Fundamentally, peptide therapies give cells the ability to change cell behavior and to handle stress better. Peptide therapies are natural modulators of cell signaling. The cell changes behavior and can adjust to stress, aging, etc… and can manipulate the genome with signals going from the mitochondria (where energy is made by the cell) to the nucleus through MOTS-C.  You can get started and just use a growth hormone releasing peptide (GHRP), eg, Ipamorelin by itself without spending a lot of money to see if your sleep improves and bone density improves. Use a GHRP together with bio-identical hormones and get great results.  There are 7,000 natural peptides in the body. There are currently 60 FDA-approved peptides in clinical use. There are now 140 clinical trials happening at this moment in time (October 2018) and there are some 400-500 clinical studies being set up right now. It’s growing into every silo of medicine right now. As a forward-thinking medical practice, we now embrace peptide therapies as an additional mainstay treatment for acute and chronic illness. Our armamentarium of tools has increased. 

Peptide therapies have a variety of applications such as immune enhancement; accelerates injury repair to muscles, reverses sarcopenia (loss of muscle), tendons, bones, nerves; progressive fat loss and improved bone mineral density, increase in Testosterone by increasing pulse size and frequency, decrease inflammation in the brain and the rest of the body, natural release of growth hormone, improves sleep. It’s easiest to think about peptides in these easy to remember ways. Here is how: 1. Hormone optimization, 2. Weight loss, 3. Sexual Functioning, 4. Healing and Repair.

1. Hormone Optimization and Growth Hormone Secretagogues: CJC-1295 without DAC, Ipamorelin, Tesamorelin, GHRP-2, GHRP-6

2. Weight Loss options: GH-191, GHRP, GHRH/GHRP, AOD-9064, Melanotan II, Frag 176-191 (an AOD knockoff, not effective), Thymosin Alpha-1, Cerebrolysin, DSIP, PEPCK, GLP 1R agonist. 

3. Sexual Enhancement and Function: Melanotan II and PT-141.

4. Healing and Repair: GHK-Cu, BPC-157, Thymosin Beta-4, AOD +HA, LL-37, GHRH, MGF and PEG-MGF.

Peptides, as signaling substances, help reclaim efficiency of hormone receptor sites. In other words, if you take some thyroid medicine, eg, T3 (active thyroid hormone), and you don’t see improvement in the labs, it may be that the receptor site is not working properly. Peptides and certain other nutrients can help improve the functionality of the receptor so that the hormones we give work as intended. Importantly, peptide therapy works best in the background of great nutrition, cortisol balance, and the removal of environmental toxins.

The melanocortin system incudes Melanotan II and Bremelanotide (PT-141). Melanotan II increases melanogenesis for photoprotection and increased tanning, plays a role in improving autoimmune disease, eg, Lyme disease. Plays a role in sexual dysfunction and can improve libido (increases sexual arousal) and erectile dysfunction in men (and sexual desire in females) through the CNS, and not through the Cardiovascular System which is the way medicines like Cialis, and Viagra work. Has significant anti-inflammatory disease. Works through the vagal /cholinergic response and affect the immune system.   Can affect appetite and cause weight loss. Works well with intermittent fasting. Activation of the vagus nerve leads to cholinergic signaling and inhibits tumor necrosis factor (TNF) and other pro-inflammatory cytokines overproduction (Cholinergic anti-inflammatory pathway). This pathway is activated by Melanocortin 3R and 4R receptors. This pathway is critical and is significant in anti-inflammation in the brain. This plays a role in neuroprotection and is also cardioprotective, too. The melanocortin system peptides can be used with Thymosin alpha-1 to balance Th1 and Th2 issues. This can also be used with DSIP with Glycine where you can upregulate glutathione peroxidase and superoxide dismutase. This gives us new approaches to autoimmune diseases. Immune cells have melanocortin receptors 1,3,5. Melanocortin receptor 3,4 is in the brain. Melanocortin receptor 4 plays a role in appetite control. The adrenal cortex is melanocortin 2. Alpha melanin-stimulating hormone reacts with all 5 receptors. Melanotan receptor 1 is on the endothelial cell. Melanotan 1 does not cross the blood-brain barrier. Melanotan 2crosses the blood-brain barrier. Melanotan 1 will not give you sexual desire effects but will give you tanning and is responsible for melanogenesis. Melanotan 2 gives you both tanning (sunless tanning) and sexual desire. In women, they can increase pigmentation and more freckles than with men.   Nota bene: The face and hands may get darker than the rest of the body. The use of Melanotan 1 is an art, follow the skin pigmentation to determine dosing adjustments. It has the cosmetic effect of tightening the collagen in the face. Melanotan 1 and Melanotan 2 are effective for autoimmune conditions like Hashimoto’s thyroiditis (may also use Thymosin alpha-1). Psoriasis may also be treated by Melanotan 2, but when treatment is stopped, the disease will come back. Melanotan 2 works through the vagus nerve through the cholinergic anti-inflammatory pathway. Can be useful for Seasonal Allergy because of the anticholinergic effects. Can be used on a daily, or regular basis vs. PT-141 (bremelanotide) which should only be used twice weekly to prevent desensitization. Melanotan 2 is neuroprotective, as well as plays a role in decreasing opioid addiction and ethanol consumption. Melanotan 2 improves libido and erectile dysfunction in men. Melanotan 2 plays a role in appetite and metabolism.

***Caveat emptor (Buyer beware)! Swiss Analytic Labs claims to have tested most if not all peptides advertised on the internet. They say that approximately 80% of these peptides are either adulterated or fake. Be particularly skeptical of marketing for very inexpensive peptide therapies. It simply is impossible for reputable companies to manufacture these products and make money at very low prices. ***

Here are the peptide therapies: 

AOD 9064 stands for Anti-Obesity Drug and is a peptide fragment found within Growth Hormone (the last 15 amino acids),  that is responsible for the substantial weight loss effects that are seen when using Growth Hormone. Growth Hormone causes weight loss of both visceral (deep) fat and retroperitoneal fat, whereas Testosterone and exercise are responsible for the superficial fat loss. Affects lipid metabolism (women greater than men). Best for weight loss of 20-30 pounds.  Promotes chondrocyte production of collagen and proteoglycan. Enhances hyaluronic acid.  The success rate for weight loss improved with work-outs or fasting. It also helps prevent fat build up and increases the NAD+/ NADH ratio, great for the cells and for stem cell renewal. It is best used for weight loss in combination with a Growth Hormone Releasing Hormone (GHRH), and a Growth Hormone Releasing Peptide (GHRP). AOD with HA (hyaluronic acid) useful for cartilage regeneration in knee, hip, shoulder, ankle, and tendinopathies. AOD with HA-also good for trigger point injections.

Examples of GHRH’s include Sermorelin, GRF 1-29, modified GRF 1-29 (CJC-1295 without DAC(makes the pituitary follow the natural pulsatile release to increase Growth Hormone, promotes muscle growth and fat burning and may help with sleep), CJC-1295 with DAC (the DAC-drug affinity complex- increases the half-life of the product by several days and elevates Growth Hormone and IgF1 levels after a single administration), Tesamorelin. Examples of GHRP’s include GHRP-2 (reduces atrophy in muscle, potent stimulator of Growth Hormone secretion, with minimal stimulation of Prolactin and Cortisol, increases growth velocity in children, and improves appetite with weight gain in patients with anorexia ), GHRP-6 (actively increases ghrelin in the stomach, restores Growth Hormone secretion in obesity, and improves phase 2 sleep), Ipamorelin (plays a role in nitrogen retention, the mildest of the group and with large doses does not produce prolactin or cortisol elevations, but does give a large release of Growth Hormone without desensitization side effects ), and Hexarelin (has cardioprotective effects, and the strongest of the group, and gives the biggest pulse of Growth Hormone, but there may be an elevation of prolactin and cortisol transiently, and desensitization can occur regardless of dose so use sparingly).  MK-0677 is fraught with side effects such as involution of receptor sites in the brain and irreversible neurologic damage. It also elevates cortisol and increases depression and anxiety.

The GHRH’s regulate Growth Hormone production and release, the neurochemical regulation of sleep, and much more. The GHRP’s antagonize the release of Somatostatin, and enhances the release of GHRH and increases Growth Hormone release. The GHRP’s also have stress protective benefits, anti-anxiety & anti-depression effects and can stimulate to the production of Nitric Oxide (NO) from endothelial cells. Also has muscle repair function and anti-inflammatory effects.

BPC-157 (Body Protection Compound-157)  by itself does nothing which makes it very safe to use at recommended doses. It has no side effects, no toxicity, and no drug interactions. It helps the body to achieve homeostasis.  It is a powerful cell signaling messenger that decreases inflammation and accelerate healing (muscle, brain, bone, tendon, nerve, ligament, cornea, intestines, as examples). It increases fat loss, improved immune function, well being, and bone mineral density.  Some patients claim that their chronic pain has been substantially reduced. BPC-157 can help you heal faster from injury to bone, muscle, ligament, tendon, nerve, brain, teeth, intestine, cornea via cell signaling. This peptide responds specifically to injury. It also has an influence on neurotransmitters related to stress, anxiety, mood, and behavior via its effects on the serotonergic, dopaminergic, GABAergic and opioid systems. May help with depression.  It has effects on the GI tract via its anti-ulcer, cytoprotective effects. It improves GI mucosal integrity (anecdotal info for healing leaky gut 500mcg, orally, twice daily).  It improves nitric oxide (NO). Useful in weaning patients off Proton Pump Inhibitors (PPI’s) with zinc carnosine over a period of a month. Induces F-actin formation. Can be used after initial use of steroids for acute anti-inflammatory purposes thus prevents the long-term adverse effects of steroid use. Decreases neuroinflammation. Ameliorates alcohol and opioid withdrawal symptoms (may be combined with DSIP), and opposes alcohol intoxication. Helps with homeostasis of dopaminergic and serotoninergic systems.  Improves nerve (axonal and myelin sheath) regeneration. It rapidly and permanently counteracts QTc prolongation of the heart caused by neuroleptic medicines (Haldol, etc) and prokinetics. Intranasal use for Lyme and Mold brain fog.

Cerebrolysin is a neuro-regenerative and neuroprotective peptide. It has neurotrophic repair properties similar to Nerve Growth Factor (NGF) and Brain-Derived Nerve Growth Factor (BDNF). It is a low molecular weight peptide that can cross the blood-brain barrier. Can be used for Traumatic Brain Injury (TBI) and Ocular Migraine Headaches, TIA’s, Stroke, Post Stroke Recovery, and Mood Dysregulation. It can be used to increase memory and learning and can improve synaptic function and synaptic density. Protects nerves from free radicals and oxidative stress damage and improves the metabolic activity of neurons, and protects neurons from neurotoxic effects of glutamate. Improves synaptic functioning.   Enhances cognitive function, memory, learning, creativity, and motivation. It can cross the blood-brain barrier and decreases beta-amyloid formation and deposition as well as Tau protein phosphorylation. It has a positive effect on behavior and neurotrophic stimulation. It can also be used for mood dysregulation, traumatic brain injury (TBI), concussion, stroke, trans-ischemic attacks (TIA), Alzheimer’s disease. In dementia, improves neuronal cytoarchitecture which results in improved cognitive and behavioral performance. Consider doing a trial in those with Apo E 4 (3/4, or 4/4) with cognitive impairment. This can help mitigate the continued cognitive impairment. Significant improvement was seen in those with mild to moderate dementia. 

Deep (or Delta) Sleep Inducing Peptide (DSIP) This peptide not only helps regulate sleep by way of improving the circadian function of sleep (mostly stage 4, slow wave sleep, when growth hormone is released) and decreasing wake ups throughout the night. It is not a sedative drug. It is also neuroprotective (prevents neuronal death) prevents excitotoxicity,  and increases glutathione peroxidase and Superoxide dismutase (SOD) in the brain which increases oxidative phosphorylation in the brain, and hence, improves mitochondrial function and LH release which can boost Testosterone levels by 100-200 points. There are no significant side effects from treatment. Oxidative stress in the brain causes an age-associated decrease in Testosterone. DSIP improves this process in the brain, where it can also help lower feelings of stress by lowering ACTH. This peptide has also been shown to decrease alcohol and opioid withdrawal (and decreases chronic pain). It has a growth hormone releasing response in a physiologic way.

Epithalon literature is mostly from Ukraine and Russia. It regulates the cell cycle to upregulate polymerase activity. The peptide is from the pineal gland, improves the sensitivity of the hypothalamus, and normalizes the function of the anterior pituitary.  It is an anti-aging peptide for short-term use (up to 10 days a year or twice a year). 33% increase in telomere length by inducing telomerase activation and elongation and also prevents chromosome fusion. It is able to overcome the Hayflick limit of cell divisions (by 10 more divisions). Human studies for 12 years, showed decreased mortality by 28%, and a two-fold decrease in cardiovascular mortality. It also has tumor suppression activities. Epithalon combined with Thymalin over a 6 year period decreased the mortality rate 4.1 times that of the control group. In human elderly studies, Epithalon has been shown to increase SOD and Glutathione peroxidase (just like DSIP, and Kisspeptin), complete normalization of antioxidant indices, reduction of lipid peroxide oxidation products, improved melatonin and immunity (both cellular and humoral). Other studies in the elderly showed: increased glucose utilization, increased insulin sensitivity, increased HDL, lowered LDL, lower BP with decreased peripheral resistance, and improved tissue repair. In other human cancer trials: restored cellular immunity, and decreased recurrence and metastasis for 10 years. In breast cancer, patients showed partial or complete tumor regression, improved leukopenia and immune function, and prolonged patient lives.

GHK-Cu (GHK-copper) modulates copper into cells. Can accelerate change from inflammation to a healing phase via decreasing TNF alpha and beta, and decreasing IL-6.   It increases SOD (copper and zinc-dependent) and that leads to a decrease in Reactive Oxygen Species (ROS). Decreases ulcers and infections. Decreases fibrinogen and metastasis of cancer.  Increases myelin and cell regeneration and increase nerve density.  Plays a role in cosmesis and also has been shown to boost self-confidence.

IGF-1 (Insulin-like Growth Factor 1), aka, Somatomedin C.  It’s very similar to insulin. In the brain, it plays a role in neural development and myelination. It is anti-inflammatory. In the heart, it has vasodilatory effects. In muscle, plays a role in muscle development and helps rebuild muscle in a more efficient way. It mediates the effects of Human Growth Hormone. It improves muscle, bone and cartilage tissue. It helps improve connective tissue healing. It plays a role in adipocyte differentiation and regulation. It improves the anti-oxidant defense system. Utility: Conditions needing soft tissue enhancement- muscle, tendon, ligament repair from sports injuries. Looks for specific results over short periods of time. It doesn’t stop the amount of scar tissue made, however (use with TB-4, which decreases scarring). Useful for Diabetes I and Insulin Resistance. It improves insulin sensitivity. Useful for weight loss and metabolic syndrome. Improves bone density. Decreases neural-inflammation.  Low level is associated with CV events and increased mortality rate. It can play a role in those susceptible to cancer so use for short-term, specific uses. High levels are associated with cancer risks (breast -premenopausal-, prostate, colorectal). We are trying to use it in physiological levels only for best results.

Ipamorelin is a Growth Hormone Releasing Peptide (GHRP), anti-depressant, anti-anxiety, protective of stress, potentially neurologically protective.

Kisspeptin 10 was developed in Hershey, PA. (home of the Hershey kiss). This peptide increases Testosterone for men with primary hypogonadism and men who lose Testosterone from the aging process. This peptide works by increasing the pulse frequency and pulse size of LH. Testosterone levels may rise 100-250 points. Kisspeptin 10 has also been shown to be better than HCG for increasing testicular size. There is no feedback inhibition. There is physiologic Growth Hormone release, too.

LL-37 is an antimicrobial peptide classified as a Cathelicidin and is involved with our innate immune system of defense against bacterial invasion, antiviral and antifungal activity on mucous membranes, increases epithelial stiffness and decreases permeability to bacterial invasion; can improve treatment of Cystic Fibrosis. Also, improve treatment for Respiratory Syncytial Virus (RSV) and Influenza A via damaging viral envelope and disruption of viral particles. Has antifibrotic effects and inhibits pro-inflammatory responses of NF kappa beta from LPS (via decrease TNF alpha, and IL-6). Interestingly, it decreases gut permeability via improved tight junctions (claudin, occludins). Can help protect against pathogen-mediated intestinal inflammation. Powerful anti-microbial and anti-inflammatory. Useful in Crohn’s and Ulcerative Colitis. In the Diabetic gut, it improves tight junctions and microflora. With C. difficile, it can decrease inflammation (IL-6).

MGF (mechanical-growth factor) is a peptide in development. It is an isoform of IGF-1 called IGF-1Ec. It is produced locally. It is activated in the heart and the brain by ischemia to activate mRNA coding for the isoform IGF1-Ec. This acts locally to increase anabolism, increase stem cell pool, stimulates satellite cells to make new cells, not grow them as skeletal muscle fibers are unable to divide. MGF expression is significantly increased following mechanical stimuli to muscle, bone, and tendon.  Resistance exercise and skeletal muscle stretch/overload, both contribute to increases in IGF-1Ec. In response to stretching and damage to muscle, MGF is vital for protein synthesis, mRNA transcription, and activation and proliferation of satellite cells. Satellite cells are signaled to replicate by MGF. Satellite cells are prevented from going forward until they fuse with muscle fibers and when they adopt a myogenic program. It’s rapid induction followed by fall of in a couple of days in response to stretching or damage to the muscle, or by ischemia in the brain or heart. This works as a proliferator of cells. This works in concert with Growth HormoneMGF promotes endothelial cell growth. MGF has been shown to improve cardiac function post-MI (myocardial infarction commonly know as a heart attack). It prevents a decrease in left ventricular ejection fraction, reduces post-infarct expansion by inhibiting post-infarct apoptosis (cell death). Helps with the development and repair of neurons. It decreases oxidative stress in the brain as well as NMDA-expressed excitotoxicity. It is also expressed in osteoblasts in response to mechanical stress. MGF reverses sarcopenia. Applications are seen in conditions needing anabolic enhancement, soft tissue repair of ligaments, tendons, muscles from injury; muscle growth; cardiac ischemia problems, brain neuroprotection/ ischemia; age-related sarcopenia. MGF and all IGF’s decline with aging. PEG-MGF is pegylation of MGF and is a peptide in development. It is an attachment of polyethylene glycol to the peptide. The pegylation process acts as a protective coating and stabilizes the MGF molecule.  It protects the MGF molecule from enzymatic and receptor inhibition and increases PEG-MGF half-life to several days (48-72 hours). PEG-MGF is useful in muscle repair or hypertrophy (specific training). The PEG is inert and doesn’t bind to other substances in the body and has rapid urinary excretion. For effects upon muscle, use MGF 600 mcg injected SQ to muscles three times a week to increase proliferation of muscle. The day after the workout you may wish to use IGF1-LR3(100 mcg/ three times a week) that works on the recovery state of muscle. Stay below 2mg total per week.  Don’t use for more than 10 days consecutively and be cautious with hypoglycemia.

Melanotan II isa melanocortin. It works through the brain/ CNS where it causes tanning and naturally makes a woman and a man sexually aroused. Improves libido and erectile dysfunction in men. Caution: may raise blood pressure and may lead to priapism (sustained erection for over an hour) with high doses, and may cause GI upset which may be prevented by coffee, or Xantac.

PT-141 (Bremelanotide) is a melanocortin receptor agonist. Has a high affinity for melanocortin 4 receptors. Improves sexual experiences for men and for women. Improves female sexual dysfunction and erectile dysfunction in males. It acts on the CNS and elicits a more desirous sexual response. GI effects are not as pronounced as with Melanotan 2, but it has been shown that if you do experience nausea, you can use Xantac 150mg, or drink a cup of coffee prophylactically to prevent nausea, or use a lower starting dose prevents nausea. They can also develop some freckles (reversible), even though they are not supposed to become tan with this product (more pronounced in women). Caution: may raise blood pressure, and cause tachycardia, and may cause GI upset.

PEPCK stands for phosphoenolpyruvate carboxykinase. It is an enzyme used in the Krebs Cycle that converts OAA to PEP.  It is involved in the production of gluconeogenesis in the liver and brown and white fat. It plays a role in fat loss, improved performance, and endurance.  If you are trying to improve preformance, you are going to have to improve and adjust lactate threshold and PEPCK helps do this. PEPCK provides a mechanism to control lactate. If you are going to improve the NAD+/NADH ratio of the cell, you are going to increase the efficiency of the cell. PEPCK, fasting, ketone esters, GHRH’s and GHRP’s also improves the NAD+/NADH ratio. This ratio is the ultimate efficiency to evaluate cell function. PEPCK increases glycogen in muscles, decreases muscle fatigue, and increases lactate threshold.

N-Acetyl Semax is a fragment from ACTH. It is not a melanocortin. It is neuroprotective and inhibits histamine release (through its Proline-Glycine-Proline ending sequence). It also reduces vascular permeability.  Nasal spray or SQ. It elevates BDNF in the hippocampus and in the cerebral cortex. It acts as an antidepressant and anxiolytic and attenuates chronic stress. It is a potential melanocortin antagonist (3 and 4 receptors). Other medical uses: Stroke, TIA, Memory, Cognitive Disorders, Boosts Immune System, Peptic Ulcers, Optic Nerve issues. Acts as a brain anti-oxidant. It counteracts the inhibition of learning and memory occurring from toxic heavy metals and counteracts neurotoxic effects. It promotes the survival of neurons secondary to hypoxemia and glutamate neurotoxicity. It contributes to mitochondria stability when under stress. It increases the amount and mobility of immune cells. It can be alternated or mixed with Selank.

Selank shows a variety of effects such as decreased histamine response from mast cells, decreased vascular permeability,  ulcer control meaning increased ulcer healing (from alcohol or stress), allows you to relax and concentrate, helps modulate IL-6, increases brain-derived nerve growth factor (BDNF) in the hippocampus, increases neuroplasticity and stem cell differentiation, has anti-depressant, anxiolytic effects that come on quickly, useful for Generalized Anxiety Disorder (GAD) and shows no sedation/addiction/cognitive loss. has anti-viral activity, regulates inflammation and decreases tumors in breast cancer, helps balance the sleep-wake cycle. Useful to transition from Growth Hormone to using a GHRH/GHRP as it decreases anxiety.

Tesamorelin is a growth hormone releasing hormone (GHRH). It stimulates the release of growth hormone and increases the amplitude of the pulse. It is a fragile peptide so it needs to be refrigerated after being reconstituted and used immediately. Tesamorelin is a good peptide to use if you transition from the use of Growth Hormone to a GHRH (best used with a GHRP, such as Ipamorelin). It has been successfully used to treat HIV + lipodystrophy, as well as to increase lipid metabolism, improve vascular health, control inflammation, and more.

Thymosin alpha-1 modulates innate immunity boosting Natural Killer cells. If you get sore throats and colds multiple times each year, this peptide can help you. This peptide can be used for autoimmune issues in general.  It stimulates T cell production,  decreases the production of pro-inflammatory cytokines, Improves Th1 response, balances Th1/Th2. It dampens immunity (by upregulating IL-10). Enhances dendritic cells, and antibody responses. It has anti-tumor effects and decreases oxidative damage.  It improves tolerance to stress. It increases anti-oxidant and glutathione production.  It improves microcirculation as well as tissue repair and healing. Inhibits viral replication. Applications: improves autoimmune disease, chemical sensitivity,  allergies, cancers, Hepatitis B and C, HIV/AIDS, Malignant Melanoma, and other (particularly stressful situations, eg, air travel, that bring out Shingles, and Seasonal Allergy).  Also, Lyme disease, Chronic Fatigue, Fibromyalgia. Adjuvant to Flu vaccinations in Geriatrics, sepsis, Dysbiosis (along with BPC-157). Best use for Hashimoto’s Thyroiditis is to use daily to lower antibodies (600 mcg/day) instead of every 3 days as used for other conditions. Works well to decrease brain fog of chemo patient (along with BPC-157, and DSIP). There are no documented adverse effects to date (10/20/18).

Thymosin beta4 (TB4) addresses inflammation, immune dysregulation, and reactive oxygen species that underlie chronic illness and age-related decline. Promotes healing via upregulation of G-actin formation. Increases cells involved in healing. Improves cell migration to the site of injury. It decreases scar tissue fibrosis (reduces levels of myofibroblasts). Anti-inflammatory. Promotes angiogenesis and differentiation of endothelial cells. Increases collagen deposition, and is cytoprotective. Improves hair growth. Useful for stroke, and traumatic brain injury (TBI) when used with BPC-157. Also supports immunity and is neuroprotective. Useful for soft tissue repair: tendons, ligaments, muscles, also post-infarction of the myocardium and decreases sarcopenia.  Applications for venous ulcers, and ischemic strokes. Cardioprotective, and useful in Non-Alcoholic Fatty   Liver Disease (NAFLD) by decreasing hepatic fibrosis and decreases proinflammatory factors and oxidative stress. Can be used with BPC-157. Prevents adhesions & fibrous band formation in injured tissue. Protects and restores neurons post-TBI. Works like BPC-157 in that it is a cell-to-cell signaling molecule. Used for patients with sepsis in ICU’s.

Peptide therapy plus Bio-Identical hormones – SynergyPeptides help reclaim the efficiency of receptor sites so they work better (and you won’t need as much hormone to get the effects you seek).

Peptides useful for:

Hormone Optimization, Growth Hormone Secretagogues:  CJC-1295 (without DAC), Ipamorelin, Tesamorelin, GHRP-2, GHRP-6. 

Weight Loss Options: GH-191, GHRP, GHRH/GHRP, AOD-9064, Melanotan II, Frag 176-191 (a knockoff of AOD, not effective), Thymosin alpha-1, Cerebrolysin, DSIP, PEPCK, GLP 1R Agonist. 

Sexual Enhancement and Function: Melanotan II and PT-141.

Healing and Repair: GHK-Cu, BPC-157, Thymosin Beta-4, AOD+ HA, LL-37, GHRH.

Lifestyle & Supplement support for Peptide Therapies: (from lectures by Dr.  Seeds and by Dr.  LaValle)

No smoking or forget doing peptides.

Adequate sleep.

Only PROTEIN within 30 minutes of taking injections.  No fat, or carbs.

Do periodic fasts.

Exercise for best peptide therapy results. Also,  1 hour before workouts, supplements like Phosphatidic acid and works through mTOR signaling (mechanistic Target of Rapamycin) and within 1 hour after workouts (branched-chained amino acids, especially with high levels of the amino acid LEUCINE) for best exercise or stretching results. During workouts, supplement in OJ with L-glutamine,  D-Ribose). The longer the mTOR signaling the longer the net protein synthesis you create. (Ornithine ketoglutarate also works through mTOR signaling).

Creatine: drives tissue anabolism. Great for older people who lack muscle mass.

Arginine: helps make growth hormone (take with Vitamin C) by suppressing somatostatin secretion. Do not take with exercise. You will not make additional growth hormone.

Glutamine: supports GI mucosal integrity, cellular repair, and healing. Supports growth hormone levels.

Alpha-GPC: taken 90 minutes before work outs shown to increase growth hormone levels substantially. How? it increases acetylcholine. Acetylcholine increases the signal release of growth hormone. Improves memory (one of the best supplements available).  Helps to balance the sympathetic and parasympathetic nervous system.

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Weight Loss

First and foremost: balance your hormones. Testosterone helps remove superficial fat. Growth Hormone helps remove both visceral (deep) fat and retroperitoneal fat.  However, this is just the start.  As you know, achieving healthy, sustainable weight loss is not so easy. Other factors may be involved such as: food sensitivities, allergies and addictions; neurotransmitter deficiencies, the need for detoxification, reduction of inflammation, sleep deprivation, yeast issues,  the need for effective exercise and other issues that play roles in weight loss.  Each of us has different needs. The aim of our work is for you to succeed in weight loss and having a healthy, toned, slender body.

Second: we offer the Pathway Fit gene testing that determines which kind of diet works best for you (recommendations are individualized and customized) and which kind of exercise program will work best for you to achieve weight loss. The strength of the science for the recommendations is also rated. For example, a 4-star **** gene rating means that there have been over 2,000 people in a study that has been replicated at least once, a 3-star *** gene rating means that a study with at least 400 people has been done that may or may not have been replicated, etc…  The genes not only relate to metabolism but also those that showcase exercise, eating behaviors and other components that can disrupt and sabotage weight loss.  Some of us are, ‘hard-wired to fail’ at diets because we do not have this valuable information that keeps us stuck and prevents us from realizing our weight-loss goals. Knowing the best diet and best exercise program for weight loss based upon your genes gives you the information you need to know to now realize your weight-loss goals.

Here is, “Think you’re weigh thin”, by JJ Virgin. Listen to a fantastic audio that JJ has put together for 20 tips for weight loss. Implement your favorite two or three and start doing them TODAY! Listen to audio.

Third:  detoxification to remove xenoestrogens from the body which prevent you from losing weight (see Gene Testing and Other Testing section for more information about xenoestrogens). Lose the wheat, lose the weight, says New York Times bestselling author Dr. Davis in his book, ‘Wheat Belly’. Dr. Davis states that glidain and wheat germ aglutinin (found in wheat) are toxic to all human beings. Watch video.

Fourth: peptide therapy. The peptide AOD,  which stands for Anti-Obesity Drug, is really a peptide and is a fragment of amino acids found within growth hormone. This peptide plays a role in weight reduction seen in growth hormone. Growth hormone causes reduction of fat in the deep fat and retroperitoneal fat, whereas Testosterone causes a reduction in superficial fat. AOD can be combined with growth hormone releasing hormones (GHRH’s) and growth hormone releasing peptides (GHRP’s). Success is significantly augmented by exercising or fasting. See section on Peptide Therapies for more information.

Finally, the fun and pleasure part: weight loss as a function of pleasure. Do you feel like you are, ‘Stuck in a rut of sitting on your butt’? as Theresa Stevens is often quoted asking. Lose weight by dancing! Theresa further says, “As you love your body, your body will naturally become the body you love.’ To view and to purchase Theresa’s program: Watch video

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Annatto Tocotrienols are the best source for Tocotrientols and play a significant role in the prevention of cardiovascular disease and much more. See videos from Dr. Barry Tan, Ph.D. on Youtube.  See video. and See another Video.

By measuring your current hormone levels, treating you, and then re-measuring your subsequent hormone levelsthis is the safest method for bringing your hormones into balance. We resolve hormonal imbalance and put things into hormonal balance.

Why Should You Consider BHRT?

Bioidentical hormone replacement therapy helps improve or eliminate hormonally created symptoms, such as PMS symptoms, the symptoms of Andropause (from low male hormones such as testosterone), and the symptoms of menopause misery (the hot flashes, vaginal dryness, night sweats, belly fat, dry skin, memory loss, and fatigue) to improve your energy, memory, mood, and sexual functioning.

We can help you become more stress-resilient to avoid burnout. We can improve the function of your thyroid and can help you normalize TPO antibodies if you suffer from Hashimoto’s thyroiditis, replenish low testosterone, oestrogen, progesterone, DHEA, cortisol, pregnenolone, oxytocin, growth hormone, insulin, parathyroid hormone, and others. We use natural hormones to help create balance, which can protect you from the development of breast cancer or endometrial carcinoma.

We also offer Estrogen Metabolism Gene Testing, which can indicate what abnormal genes you have in estrogen metabolism. Once we discover your vulnerabilities, we can offer you targeted supplements to help re-route estrogen down a healthy pathway, instead of one that predisposes you to developing breast or endometrial cancer.

Gene testing, as we say, is the clarion call, the jarring gong of reality to let you know what your genetic vulnerabilities are, and what we can do about them. By undergoing gene testing, and taking proper action via targeted nutritional supplementation, we can lower the risk of breast cancer.

Who Should Do Gene Testing?

All women have this option offered to them. It is especially important if there is a previous history of breast cancer, or a family history of breast cancer. Of course, if there is an interest, all patients can do this testing now. It’s not especially pricey.

In addition, we not only offer gene testing for estrogen metabolism, but also for heart disease, stroke, and osteoporosis genes. If there is a family history of these conditions, patients are offered this kind of testing at the beginning, or anytime during their treatment. However, we often offer this before the start of bio-identical hormone replacement therapy.

Once these abnormal genes are identified, we can impact their expression through a variety of ways — be it lifestyle modifications, or through supplemental vitamins and minerals that make these pathways work properly.

In addition to these gene tests, we offer poly-pharmacy (multiple medicine) gene testing to see the likelihood of drug/drug interactions that will make the metabolism of the medicines slow down tremendously (consequently making you need less of it to treat your ailment) or speed up significantly (consequently requiring you to adjust your dosage to make them effective).

If you have never felt well, or have bouts of depression throughout your life, we look at your hormones and also offer a total methylation panel gene testing. We may uncover some relevant yet previously unknown connections, and help empower you to overcome these seemingly unsurpassable circumstances.

When we find abnormal genes, called snips (single nucleotide polymorphisms), we can give targeted nutrients that help these genes function better. Along with some proper lifestyle changes, you will have the opportunity to live the life you love.

How BHRT Helps Menopausal Women

Bioidentical hormone therapy for women: It’s not a fun experience to be visited by the ‘Seven dwarves of menopause’ Suzanne Somers wrote about: itchy, bitchy, sweaty, bloaty, sleepy, forgetful, and all dried up!

All the menopause symptoms are really a result of Progesterone deficiency. Supplementation of progesterone will help alleviate these symptoms. We look at all of the sex hormones, in addition to thyroid and adrenals, and by looking and treating the totality of your situation, we have the best chance of obtaining hormonal harmony and balance, and you become yourself again, symptom-free!

Menopausal symptom manifestation in post menopausal women is due to them typically having their ‘tank’ empty, and just flying on fumes. This means their hormone output is low, and they will benefit greatly by replenishing them through bio-identical estrogens (estradiol and estriol, to help alleviate vaginal dryness), bio-identical or natural progesterone therapy (creams or pills), and testosterone (yes, women need it too to help prevent loss of muscle and bone).

It typically takes six to nine months, in general, for hormone replenishment to occur,  and we monitor hormone levels every three months unless there is a special need for earlier testing.

The goal is not only to normalize lab results, but to have you feeling normal, like yourself, again. Remember, you are the patient, and we are treating you — you are not a lab test!

Also, we do not use synthetic estrogens, only bio-identical hormones —  the hormones your body has made all through your life. We also never use oral estrogens, which can increase the risk of gallbladder issues, and they can alter your body lipids in an unfavorable direction.

By sticking to topical application with estrogen creams, or by putting the cream in the vagina, we are able to bypass the liver and avoid these problems. We also, in the appropriate patient, treat with bioidentical hormones after breast cancer treatment.

Although controversial, many women are desperate for symptom relief. In certain groups of women, we can administer them safely with regular monitoring at different times. Clinical trials have shown this can be done safely and effectively.

Bioidentical Hormone Replacement Therapy for Men

Testosterone replacement and key nutrients help men avoid becoming the proverbial ‘grumpy old man.’ These men have a pervasive sense of fatigue and loss of mental and physical sharpness.  

Therapy reverses this, and the effect is a better quality of life. There are multiple ways to increase testosterone in men. We pay particular attention to younger men, as the causes for low testosterone are variable. Treatments offered include Clomid stimulation testing  (Clomiphene) , HCG stimulation testing (human chorionic gonadotropin), and testosterone (creams, gels, injections), and peptide therapies such as Deep or Delta Sleep Inducing Peptide (known as DSIP) and also Kisspeptin.

What is peptide therapy? This treatment sends signals to accelerate your body’s ability to heal, remember, have sexual desire, improve function, and more.

For all men to achieve the beneficial effects of testosterone replacement therapy, their total testosterone levels need to be in the upper quartile of young men.  Being within a ‘normal range’ has not been shown to obtain the beneficial effects of testosterone replacement therapy.

The benefits of testosterone therapy include: decrease in all-cause mortality, decrease in depression symptoms, and decrease in sexual dysfunction (that means good libido, sustainable erections, and orgasm).

Bioidentical Hormone Therapies for Psychological and Psychiatric Issues

For Sleep disorders, Burn-out Syndrome, Sexual Arousal, Depression, slowed progression of Alzheimer’s disease, Irritability & Anxiety, Chronic tendency to Social Withdrawal, Bipolar disorder, and Schizophrenia, the judicious use bio-identical hormones, coupled with targeted nutrient therapy, can be quite helpful.

For women, the benefits of bio-identical hormone therapy include:

  • better energy
  • better memory
  • better mood
  • improved sleep
  • prevention of frailty
  • improved muscles
  • improved bones
  • better heart health
  • improved libido and orgasms
  • better immune function
  • reduced PMS symptoms
  • reduced symptoms of menopause
  • … and more!

For men, if your hormones are out of balance, you may have some or all of the following hormone imbalance symptoms:

  1.    A pervasive sense of fatigue – you feel tired all day!
  2.    Losing mental and/or physical ‘edge’
  3.    ‘Couch potato’ after 5 pm
  4.    Workouts do not produce the results of the past
  5.    Aches and pains (particularly in the neck and shoulders)
  6.    Sexual functioning decreased- unable to obtain or maintain erections, less ejaculate, etc…
  7.    Loss of self-confidence
  8.    Poor sleep
  9.    Less focused thinking
  10. Depression

These symptoms can be reversed with bio-identical hormone replacement therapy. For example, testosterone replacement can sharpen a man’s focus and mental clarity, improve self-esteem and self-confidence, help prevent heart disease by decreasing inflammation, improve blood sugars, helps build bone, helps build muscle, workouts are more productive, and improves sexual functioning.

By combining the work of hormone replacement with nutritional assessments, environmental toxins evaluations, and gene testing for methylation issues and more, we offer you the best chance of becoming well and functioning at your best.

We also offer toxic heavy metals testing and treatment, assessment of environmental toxins, such as mold mycotoxins, and offer modern therapy to remove the offending substance, be it a metal or a mycotoxin.

Once diagnosed, chelation therapy based on the binding coefficient of the metals is offered. If mold mycotoxins are discovered to be present, we offer comprehensive therapy to kill the mold, boost your immune system, boost your overall nutritional status, and decrease the Herxheimer reaction symptoms that often accompany the die-off from the treatment.

These symptoms are usually headache, profound fatigue, stomach discomfort. We further offer brain fitness to quicken your thought processes, and improve your memory. We can add this for men and women as a regular component of their consults.

There are many nutrients, hormones, and other substances that improve  brain processing speed and we routinely take advantage of them, in the course of our consultation with our patients, should they request help in this domain.

The expression “You are only as strong as your weakest part” is demonstrated on a regular basis, so we attempt to address these issues so you can lead a better life.

You have to prime the pump with mild to moderate exercise and high-end nutrition if you want to get the best results with hormones. That means:

  • whey protein or protein with branched-chain amino acids (BCCAs — particularly the amino acid Leucine) in protein shakes with dietary choline of some form to balance the sympathetic vs. parasympathetic nervous system
  • beet crystals to increase nitric oxide to relax the endothelium and lower blood pressure
  • minerals such as magnesium and potassium to get optimal results.

We use functional needs testing and nutritional testing, which include organic acids testing, fatty acids testing, amino acids testing and the functional need for B-vitamins and oxidative stress markets. This kind of testing best predicts what your functional needs requirements are for different nutrients (vitamins and minerals and antioxidants).  

As you can see, bio-identical hormone replacement therapy does not stand alone. It is bolstered by:

  • great nutrition
  • gene testing with supplementation
  • removal of environmental toxins including overbearing stress (we do a thorough evaluation of your adrenals, with questionnaires, and saliva testing)
  • other hormone testing
  • lifestyle modification, which includes getting proper sleep totally necessary for weight loss goals
  • peptide therapies, which is the regenerative part of medicine

LINK LINK

Peptide therapies can bolster the effects of hormones and getting well physically, emotionally, and sexually.  

KETAMINE INFUSION CENTER NORTHERN VIRGINIA| 703-844-0184 |DR. SENDI | NOVA HEALTH RECOVERY | KETAMINE DEPRESSION PTSD ANXIETY THERAPY | KETAMINE INFUSION CENTER VIRGINIA| 703-844-0184 | NOVA HEALTH RECOVERY | FAIRFAX, VA 22101 | LOUDON COUNTY, VA 20176 | DR. SEND | 703-844-0184 | ESKETAMINE PROVIDER VIRGINIA | ESKETAMINE CENTER | ESKETAMINE DOCTOR | 703-844-0184 | ARLINGTON, VIRGINIA 22207 22213 | NASAL SPRAY KETAMINE AND THE FDA APPROVAL| DR. SENDI | ESKETAMINE PROVIDER | NASAL SPRY KETAMINE THERAPY | KETAMINE FOR TREATMENT OF DEPRESSION, PTSD, ANXIETY | KETAMINE INFUSION CENTER | KETAMINE DEPRESSION | KETAMINE PTSD | EMAIL@NOVAHEALTHRECOVERY.COM | 2220 22182 23103 22039 20197 20184 22101 22102 22066 | CBD DOCTOR CBD CENTER | 703-844-0184 | FAIRFAX, VA 22034 | 22308 | ESKETAMINE LOUDON COUNTY, VA | ESKETAMINE ANNANDALE, VA | ESKETAMINE RICHMOND | ESKETAMINE VIRGINIA | KETAMINE SPRAY PROVIDER IN NORTHERN VIRGINIA 22308 | KETAMINE INFUSION CENTER | KETAMINE VIRGINIA | ESKETAMINE VIRGINIA | 703-844-0184 FOR AN APPOINTMENT | CBD PROVIDER | CBD CENTER | CBD VIRGINIA | DR. SENDI | NORTHERN VIRGINIA KETAMINE | KETAMINE CENTER |Long known as a party drug, ketamine now used for depression, but concerns remain | LOUDON COUNTY KETAMINE 703-844-0184 NORTHERN VIRGINIA | ARLINGTON, VA KETAMINE INFUSION CENTER



NOVA Health Recovery | Alexandria, Va 22306 | Call for esketamine and nasal ketamine as well as IV Ketamine for depression, PTSD, anxiety  703-844-0184 < Link

Ketamine Virginia Link

Long known as a party drug, ketamine now used for depression, but concerns remain

A decades-old anesthetic made notorious as a party drug in the 1980s is resurfacing as a potential “game-changing” treatment for severe depression, patients and psychiatrists say, but they remain wary about potential long-term problems.

The Food and Drug Administration earlier this month OKd use of Spravato for patients with depression who have not benefited from other currently available medications. Spravato, the brand name given to the drug esketamine, is a molecule derived from ketamine — known as Special K on the club scene.

Ketamine has been shown in some studies to be useful for treating a wide variety of neurological disorders including depression. Regular, longtime use of it isn’t well understood, psychiatrists say, but the need for a new drug to treat depression is so great that the FDA put Spravato on a fast-track course for approval.

The drug likely will be commercially available in a few weeks, and patients already are requesting it. Restrictions around its use, though — the drug must be administered in a doctor’s office by providers who are certified with the company making it — mean it may be months before it’s widely available, and longer than that before insurers start paying for it.

“I don’t think we know at this point how effective it’s going to be,” said Dr. Craig Nelson, a psychiatrist at the UCSF Depression Center. “There have been a number of studies of ketamine, sometimes showing effects in people who were resistant to other drugs. If we can treat a different group of people, it would be a great advantage.”

Ketamine was developed in the 1960s as a surgical anesthetic for people and animals. The drug can cause hallucinations and a feeling of “dissociation” or unreality, and in the 1980s it took off as a party drug among people seeking those effects. It remained a common anesthetic, though, and in the early 2000s doctors began to notice a connection between ketamine and relief from symptoms of depression and other mood disorders.

Spravato is delivered by nasal spray, which patients give themselves in a doctor’s office. Patients must be monitored while they get the drug and for two hours after to make sure they don’t suffer immediate complications. At the start, patients will get the nasal spray twice a week for four weeks, then taper to regular boosters every few weeks for an indefinite period of time.

Studies of ketamine — and specifically of Spravato — have produced encouraging but inconsistent results. Psychiatrists say that, like most other antidepressants, the drug probably won’t help everyone with difficult-to-treat depression. But there likely will be a subset of patients who get substantial benefits, and that alone may make it an incredible new tool.

About 16 million Americans experience depression every year, and roughly a quarter of them get no benefit from antidepressants on the market. Thought scientists haven’t determined exactly how ketamine works on the brains of people with depression or other mood disorders, it appears to take a different path of attack than any drug already available. That means that people who don’t respond to other antidepressants may find this one works for them.

But a concern among some psychiatrists is that studies have suggested that ketamine may affect the same receptors in the brain that respond to opioids. Ketamine and its derivations may then put patients at risk of addiction — but research so far hasn’t explored that kind of long-term effect.

“There might be some potential problems if you used it too aggressively,” said Dr. Alan Schatzberg, director of the Stanford Mood Disorders Center, who led the research that identified a connection with opioid receptors. “The issue is not so much the short-term use, it’s the repetitive use, and the use over time, as to whether there are going to be untoward consequences.

“It would be hard for me to recommend the use of this drug for chronically depressed people without knowing what the endgame is here,” he added.

Dr. Carolyn Rodriguez, a Stanford psychiatrist who was part of the studies of ketamine and opioid receptors, said she shares Schatzberg’s concerns. But she’s been studying the use of ketamine to treat obsessive-compulsive disorder, and for some patients the results have been so remarkable that the benefits may exceed the risks.

“When I gave ketamine to my first patient, I nearly fell off my chair. Somebody said it was like a vacation from their OCD, and I was just, ‘Wow, this is really possible,’” Rodriguez said. “I want to make sure patients have their eyes wide open. I hope (the FDA approval) spurs more research, so we can really inform consumers.”

Though the new nasal spray is the first formal FDA approval of a ketamine-derived drug, psychiatrists have been using the generic anesthetic for years to study its effect on depression and other mood disorders.

In recent years, clinics have opened around the country offering intravenous infusions of ketamine to people with hard-to-treat depression and other problems. These treatments aren’t specifically FDA-approved but are allowed as off-label use of ketamine. The clinics have faced skepticism from some traditional psychiatrists, but there’s a growing ream of anecdotal evidence that the ketamine IVs work — for some people.

Aptos resident Mary, who suffers from depression and other mood disorders and asked that her last name not be used to protect her privacy, said the already available antidepressants weren’t keeping her symptoms at bay, and she frequently felt “one step away from the abyss.” When she first heard about ketamine, from a support group for people with depression and other mood disorders, she was hesitant.

“I kind of hemmed and hawed, because I’d heard that K was a street drug,” Mary said. “But then I said, ‘What do I have to lose?’ So I went and did it.”

The results were quick: Within four days, “the cloud had lifted,” she said. More than a year later, she is still feeling good with regular infusions every three or four weeks. During the ketamine infusion, Mary said she’ll feel the dissociation, which she described as feeling like she’s viewing the world around her as though it were a movie and not her own life.

She said she’s pleased the FDA approved Spravato, though she hasn’t decided whether she’ll switch from the IV ketamine to the nasal spray. She hopes that the FDA approval will give some validation to ketamine and encourage others to try it.

Mary gets her infusions at Palo Alto Mind Body, where Dr. M Rameen Ghorieshi started offering ketamine two years ago. He’s certified with the maker of Spravato — Janssen Pharmaceuticals, a branch of Johnson and Johnson — to provide the drug, though he doesn’t know when he’ll actually start giving the nasal spray to patients.

Ghorieshi said that although he’s been offering IV ketamine for more than two years, he shares his colleagues’ wariness of the long-term effects of regular use of the drug. He hopes FDA approval will encourage further research.

“At this point we’ve done 1,000 infusions. The outcomes have exceeded my own expectations,” Ghorieshi said. “But anecdotes are not clinical trials. I approach this very cautiously. What I don’t want is 20 or 30 years from now to look back and say, ‘What did we do?’”



KETAMINE INFUSION CENTER NORTHERN VIRGINIA| 703-844-0184 |DR. SENDI | NOVA HEALTH RECOVERY | KETAMINE DEPRESSION PTSD ANXIETY THERAPY | KETAMINE INFUSION CENTER VIRGINIA| Spravato | 703-844-0184 | From Popular Anesthetic to Antidepressant, Ketamine Isn’t the Drug You Think It Is | FAIRFAX, VA 22101 | LOUDON COUNTY, VA 20176 | DR. SENDI | 703-844-0184 | ESKETAMINE PROVIDER VIRGINIA | ESKETAMINE CENTER | ESKETAMINE DOCTOR | 703-844-0184 | ARLINGTON, VIRGINIA 22207 22213 | NASAL SPRAY KETAMINE AND THE FDA APPROVAL| DR. SENDI | ESKETAMINE PROVIDER | NASAL SPRY KETAMINE THERAPY | KETAMINE FOR TREATMENT OF DEPRESSION, PTSD, ANXIETY | KETAMINE INFUSION CENTER | KETAMINE DEPRESSION | KETAMINE PTSD | EMAIL@NOVAHEALTHRECOVERY.COM | 2220 22182 23103 22039 20197 20184 22101 22102 22066 | CBD DOCTOR CBD CENTER | 703-844-0184 | FAIRFAX, VA 22034 | 22308 | ESKETAMINE LOUDON COUNTY, VA | ESKETAMINE ANNANDALE, VA | ESKETAMINE RICHMOND | ESKETAMINE VIRGINIA | KETAMINE SPRAY PROVIDER IN NORTHERN VIRGINIA 22308 | KETAMINE INFUSION CENTER | KETAMINE VIRGINIA | ESKETAMINE VIRGINIA | 703-844-0184 FOR AN APPOINTMENT | CBD PROVIDER | CBD CENTER | CBD VIRGINIA | DR. SENDI | NORTHERN VIRGINIA KETAMINE | KETAMINE CENTER | NASAL SPRAY KETAMINE | ESKETAMINE PROVIDER |MAGNESIUM AND COPPER AND DEPRESSION | NEW TREATMENTS FOR DEPRESSION | LOUDON COUNTY KETAMINE 703-844-0184 NORTHERN VIRGINIA | ARLINGTON, VA KETAMINE INFUSION CENTER



NOVA Health Recovery | Alexandria, Va 22306 | Call for esketamine and nasal ketamine as well as IV Ketamine for depression, PTSD, anxiety  703-844-0184 < Link

Call NOVA Health Recovery at 703-844-0184 for a free consultation for a Ketamine infusion. No referral needed. We offer intranasal Ketamine follow up therapy as well. Alexandria, Va 22306.

Call NOVA Health Recovery at 703-844-0184 for a free consultation for a Ketamine infusion. No referral needed. We offer intranasal Ketamine follow up therapy as well. Alexandria, Va 22306.

From Popular Anesthetic to Antidepressant, Ketamine Isn’t the Drug You Think It Is

An hour before we spoke, Darragh O’Carroll, an emergency room physician from Hawaii, had just given an elderly patient a sedating shot of ketamine. The man had pneumonia and was acting confused and fidgety, making him hard to treat.

“Not only it was a pain control for him when I was putting needles into his neck, but it also kept him still,” O’Carroll says. “And with very minimal risk of lowering his blood pressure.”

Ketamine’s use as an anesthetic — and not as a party drug — is widespread, though not commonly known. In fact, the World Health Organizationestimates ketamine is the most widely used anesthetic in the world and keeps it on their list of essential medicines, a category of drugs that all developed countries should have on hand.

O’Carroll has described ketamine as his “favorite medicine of all time” in an article for Tonic, not only because the anesthetic is incredibly safe and effective, but also because of its versatility. It’s most widely used in surgery, but could also help treat severe asthma, chronic pain, and may even possess anti-tumor properties. In the last two decades, ketamine has also emerged as a potent antidepressant, able to treat symptoms of some mental illnesses in less than 72 hours.

“I think the more research that goes into ketamine, the more uses that we find for it,” O’Carroll says.

From PCP to Painkiller

Ketamine’s story begins with a drug called PCP. Yes, that PCP — phencyclidine or so-called “angel dust,” a drug that when smoked can cause a trance-like state, agitation and out-of-body hallucinations. After it was first synthesized by medicinal chemist Victor Maddox in 1956, the drug was briefly approved as an anesthetic by the FDA for its sedative properties. In tests with a wild rhesus monkey, for example, researchers put their fingers in the previously aggressive animal’s mouth and watched its jaw remain slack.

But while it was safe and effective for pain relief, the side effects of PCP soon became too obvious to ignore.

Some patients under the influence of PCP would feel like they lost their arms or legs or that they were floating in space. It could also cause seizures and delirium. Scientists began seeking a shorter-acting anesthetic without convulsant properties. In 1962, chemistry professor Calvin Stevens discovered a PCP analogue that fit the bill: ketamine.

Ketamine is a potent, sedating painkiller that can cause amnesia and is mostly used in surgery and veterinary medicine. During the Vietnam Invasion, ketamine saw widespread use in the U.S. military because it has several advantages over opioids. First, unlike morphine, ketamine doesn’t suppress blood pressure or breathing. It also doesn’t need to be refrigerated, making it useful in the field or in rural areas that don’t have access to electricity.

Ketamine’s benefits extend beyond use as an anesthetic, though — in some cases it can serve as a balm for the mind as well. A 2008 analysis found that burn victims who were given ketamine were less likely to develop symptoms of post-traumatic stress disorder, even if their injuries were more severe. Those findings have been replicated, such as a 2014 clinical trial of 41 patients, who saw their PTSD symptoms diminish within 24 hours, an effect that lasted for two weeks.

“When somebody gets one of their limbs dramatically blown off or is shot in the face, it’s a very traumatic event,” O’Carroll says. In such a situation, giving ketamine not only provides instant pain relief, it could prevent long-lasting trauma.

Because its chemical structure is so similar to PCP, ketamine can still give lucid hallucinations, such as feeling that your mind has separated from the body — a dissociative state users sometimes call a “K-hole.” One recent study based on users’ written reports even indicated that this kind of experience might be a close analogue to a near-death experience. However, these dissociative states only happen at high doses — the amount of ketamine used to for surgery and to treat depression is typically much lower.

But ketamine’s side effects are less common and easier to manage than PCP. In fact, ketamine is one of the safest drugs used in medicine today and can even be given to young children. For example, ketamine was used to sedatethe boys’ soccer team trapped in a cave in Thailand last year. Putting the kids in a tranquilized state made it easier to rescue them, and ketamine is safer than the opioids or benzodiazepines that are also commonly used as sedatives.  

Ketamine as Antidepressant

But it wasn’t until the 1990s that what could turn out to be ketamine’s most important function was discovered. A team from Yale University School of Medicine was examining the role of glutamate, a common neurotransmitter, in depression, and discovered something remarkable: ketamine could rapidly relieve depression symptoms.

“To our surprise, the patients started saying, they were better in a few hours,” Dennis Charney, one of the researchers, told Bloomberg. This rapid relief was unheard of in psychiatry.

Glutamate is associated with neural plasticity, our brain’s ability to adapt and change at the level of the neuron. Ketamine blocks certain glutamate receptors, but not others, and the end effect could be to promote the growth of new neurons while protecting old ones. This could explain how ketamine can help reset the brain, though the theory hasn’t yet been definitively proven.

The prescription meds currently on the market for depression have some major drawbacks. Drugs like Prozac or Wellbutrin can take a few weeks or months to kick in while worsening symptoms in the short term — not a good combination, especially for someone who is extremely depressed, or even suicidal.

It took around a decade for mainstream science to take notice of these early ketamine-depression studies. But once it did, ketamine clinics began popping up all across North America, offering fast relief for depression, anxiety and other mental illnesses. Patients are given an infusion — an IV drip that lasts about an hour — and many people, but not everyone, have seen rapid relief of their symptoms.

Suddenly, ketamine infusions became trendy, though the science to back up some of the medical claims is still inconclusive, according to STAT. However, ketamine infusions are rarely covered by insurance, although that is changing. A typical session can run $700, with many patients taking six sessions or more. But many of these patients have so-called treatment-resistant depression. They’ve tried other medications or therapies without success and some see ketamine as a last resort.

Steven Mandel, a clinical psychologist and anesthesiologist, has used ketamine on patients since it first came on the market around 50 years ago. In 2014, he began using it for patients with depression and opened Ketamine Clinics of Los Angeles, one of the oldest and largest clinics in the country. They’ve done over 8,000 infusions so far.

“Our success rate is better than 83 percent,” Mandel says. For his clinic, success means a 50 percent improvement of depression symptoms for longer than three months.

Ketamine’s success as an antidepressant couldn’t help but attract the attention of major pharmaceutical companies as well. In 2009, Johnson & Johnson began developing their own version of the drug they called esketamine. Rather than an infusion through a vein, it’s dispensed through a nasal spray. The FDA approved their formulation in early March. It was thefirst drug in 35 years to fight depression using a different approach than traditional drugs.

“Esketamine is a giant step forward,” Mandel says. “It means we’re not going to be demonizing mind-altering substances used for therapeutic purposes. It opens the door to research on LSD, on psilocybin, on MDMA and many other agents that could possibly relieve a great deal of suffering.”

But many clinicians have raised concerns about long-term side effects, such as heart and bladder toxicity. Others have been critical of esketamine, saying there isn’t enough data yet to suggest the drug is safe or effective. Husseini Manji, a neuroscientist who helped develop the drug for Johnson & Johnson at their subsidiary Janssen, has pushed back against these claims.

“When you line up the totality of the studies, it was really an overwhelming amount of data that was all in the same direction,” Manji says in a call. Though just two of the five late-state clinical trials showed significant results, the changes in mood in the three that fell short were “almost identical in magnitude” to the others, Manji says. It was enough for the drug to meet standards for FDA approval.

We can probably expect other ketamine-related drugs to come to market soon. ATAI Life Sciences, a company funding research on the use of magic mushrooms for depression, is developing their own ketamine depression drug. The pharmaceutical company Allergan also developed rapastinel, another ketamine-like drug, though it failed to show any real benefits for patients in later trials. Manji says this is unfortunate for people who could be helped by these kinds of drugs.

“From a patient standpoint, we were hoping it would work,” he says, even though he was not involved in rapastinel’s development. “But sometimes if you really haven’t got the mechanism right and you haven’t really threaded the needle, then sometimes you don’t see these results.”

Drug of Abuse?

Even though ketamine’s medical uses are well-established, most people have only heard of ketamine in the context of a party drug. Because of this bad reputation — and what’s perceived as growing misuse of the drug — several countries, such as China and the UK, have tried to place greater restrictions on ketamine. This would make it harder to study and more expensive in clinical use.

“If it was to ever be rescheduled, places that would be first affected would be you know places that need it most,” O’Carroll says. The WHO has asked at least four times for countries to keep access to ketamine open. “The medical benefits of ketamine far outweigh potential harm from recreational use,” Marie-Paule Kieny, assistant director general for Health Systems and Innovation at WHO, said in 2015.

So far, no countries have put greater restrictions on ketamine, and that’s probably a good thing. Ketamine has a rich history, but its future is still being written.



Esketamine Spravato Center Northern Virginia 703-844-0184| Dr. Sendi | NOVA Health Recovery | Alexandria, Va 22101 | The FDA Approved a Ketamine-Like Nasal Spray for Hard-to-Treat Depression | Ketamine Infusion Center Virginia | Ketamine nasal spray for depression |22314 | 22066 | Spravato clinic

Call NOVA Health Recovery at 703-844-0184 for a free consultation for a Ketamine infusion. No referral needed. We offer intranasal Ketamine follow up therapy as well. Alexandria, Va 22306.



Call NOVA Health Recovery at 703-844-0184 for a free consultation for a Ketamine infusion. No referral needed. We offer intranasal Ketamine follow up therapy as well. Alexandria, Va 22306.

The FDA Approved a Ketamine-Like Nasal Spray for Hard-to-Treat Depression

Dr. Sendi | Ketamine Infusion Center NOVA Health Recovery | 703-844-0184 | Fairfax, Va 22304

Treatment-resistant depression affects 1 in 3 of the estimated 16.2 million adults in the US who have suffered at least one major depressive episode. For them, two or more therapies have failed and the risk of suicide is much greater. It’s a grim prognosis.

There are few therapies for depression that resists treatment, which is why the FDA granted this new drug application Fast Track and Breakthrough Therapy status. On March 5, the Food and Drug Administration approved a new treatment called Spravato, which is an esketamine nasal spray.

On February 12, 2019, I participated in the FDA review of this drug. Practically speaking, esketamine is essentially the same as ketamine, which is a painkillerwith hallucinogenic effects and used illegally. As a member of the Drug Safety and Risk Management Advisory Committee of the FDA, I voted with the majority of that panel 14-2, to approve esketamine only for people who have treatment-resistant depression.

For more than 20 years, I have researched illegal drug use and addiction. As a medical anthropologist, my work is oriented to understanding the perspectives and behaviors of people actively using illegal drugs. My research often involves fieldwork, which means participating in the lives of people as they go about their everyday routines. This has given me a personalized and practical outlook on illegal drug use. Many of the people I currently interview are heroin injectors who first started opioid use by misusing prescription drugs.

Ketamine is not a street drug

But many drugs, especially those for the treatment of mental illness, have powerful effects on the central nervous system. How the drug is distributed and administered must minimize risk. What if the drug is addicting?

Some reports about esketamine have sensationalized this issue by referring to ketamine as a highly addictive street drug. In my research, this is not true. First, ketamine use is rare. The last time I interviewed a ketamine users was nearly 20 years ago and, since its introduction in 1964, there have been no significant trends or outbreaks in its diversion or use.

Not all illegal drugs are sold “on the street.” Street drugs are staples of the illegal drug economy, which is run by drug trafficking organizations. Prescription opioids, heroin, cocaine, and marijuana are street drugs sold in open-air drug markets, where such markets exist. Hallucinogens and exotic, designer, and other less popular drugs are rarely available in these settings. They simply do no appeal to enough users to make them profitable for drug traffickers to supply. Ketamine has always been in this second group.

Are ketamine or esketamine addictive?

Ketamine is short-acting—between two and four hours—and produces euphoria, sustained pain relief, and sedation mixed with powerful hallucinogenic effects. Taking this drug can be very unpleasant. Out-of-body experiences, time perception distortions, tunnel vision. and dissociation are common. These effects limit the popularity of ketamine and make it difficult to use habitually. A person can take heroin everyday and function. Ketamine is disruptive.

Another reason that ketamine isn’t popular on the street is that users do not have to keep using it to avoid withdrawal. There is no withdrawal syndrome associated with ketamine; when people stop using it, they do not get sick. This is actually a benefit, because fear of withdrawal is often a major motivation for the continuation of drug use. Unlike street drugs, its appeal is limited and its addiction liability is comparatively low.


On balance, the profile of ketamine is more like LSD than cocaine or opioids. People do not get addicted. This does not mean that ketamine or esketamine is safe. Its access should be restricted and use monitored by a physician.

How will people take esketamine for depression?

The manufacturer is placing important restrictions on the drug. It will not be available at local pharmacies and never for take-home use. A person receiving the treatment, which was developed by Johnson & Johnson and delivered as a nasal spray, will be under observation and care of a health professional trained in the therapy. The drug will be given in an office or approved health center, and the patient will not be allowed to drive until the day after treatment. The patient will also need to take an oral antidepressant, the FDA says.

Given its effectiveness and the proposed risk evaluation and mitigation strategy, the benefits outweigh the risks of esketamine for the treatment of depression that has not responded to other treatments. Like any new treatment, as manufacturers make this product available, monitoring it will be important to make sure the benefits outweigh the costs. People living with the misery of treatment-resistant depression need more options, and this drug should help.

Lee Hoffer is a medical anthropologist at Case Western Reserve University who studies substance use disorder and the use of illicit drugs. He was a member of the FDA advisory committee that recommended last month that the esketamine be approved for treatment-resistant depression.

MONITORING THE FUTURE drug trends Link

National Survey on Drug Use and Health




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fast-Acting Depression Drug, Newly Approved, Could Help Millions



Call NOVA Health Recovery at 703-844-0184 for a free consultation for a Ketamine infusion. No referral needed. We offer intranasal Ketamine follow up therapy as well. Alexandria, Va 22306.

Fast-Acting Depression Drug, Newly Approved, Could Help Millions

A nasal spray version of the drug ketamine has shown promise as an antidepressant, even if its properties still aren’t well understood.

Of the 16 million American adults who live with depression, as many as one-quarter gain little or no benefit from available treatments, whether drugs or talk therapy. They represent perhaps the greatest unmet need in psychiatry. On Tuesday, the Food and Drug Administration approved a prescription treatment intended to help them, a fast-acting drug derived from an old and widely used anesthetic, ketamine.

The move heralds a shift from the Prozac era of antidepressant drugs. The newly approved treatment, called esketamine, is a nasal spray developed by Janssen Pharmaceuticals Inc., a branch of Johnson & Johnson, that will be marketed under the name Spravato. It contains an active portion of the ketamine molecule, whose antidepressant properties are not well understood yet.

“Thank goodness we now have something with a different mechanism of action than previous antidepressants,” said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University. “But I’m skeptical of the hype, because in this world it’s like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away.”

The generic anesthetic is already increasingly available for depression, at hundreds of clinics around the country that provide a course of intravenous treatments, and studies suggest it can help treatment-resistant people. It often causes out-of-body and hallucinogenic sensations when administered; in the 1980s and 1990s it was popular as a club drug, Special K.

The cost for these treatments typically is out of pocket, as the generic anesthetic is not approved by the F.D.A. for depression. In contrast, esketamine likely would be covered under many insurance plans, and its side effects, though similar to those of generic ketamine, are thought to be less dramatic.

The recommended course of the newly approved drug is twice a week, for four weeks, with boosters as needed, along with one of the commonly used oral antidepressants. F.D.A. approval requires that doses be taken in a doctor’s office or clinic, with patients monitored for at least two hours, and their experience entered in a registry; patients should not drive on the day of treatment.

Esketamine, like ketamine, has the potential for abuse, and both drugs can induce psychotic episodes in people who are at high risk for them. The safety monitoring will require doctors to find space for treated patients, which could present a logistical challenge, some psychiatrists said.

The cost for a one-month course of treatment will be between $4,720 and $6,785, said Janssen, and experts said it will give the company a foothold in the $12 billion global antidepressant market, where most drugs now are generic.[L

The approval of esketamine marks a new approach to treating serious mood problems, experts said. Prozac and similar drugs enhance the activity of brain messengers such as serotonin; they are mildly effective, but they take weeks or months for their effects to be felt, and for many patients they provide little or no relief from depression. In contrast, the ketamine-based compounds — several others are being developed — work within hours or days, and are effective in some people who are considered “treatment resistant,” meaning they have not benefited from other antidepressants.

“These are exciting times, for sure,” said Dr. Todd Gould, an associate professor of psychiatry in the University of Maryland School of Medicine. “We have drugs that work rapidly to treat a very severe illness.” Dr. Gould was not involved in the Janssen study but has identified a metabolite, or ketamine breakdown product, that could be developed into another drug.

Experts with long experience in treating depression were encouraged by the news, but also chary. The effectiveness of the previous class of antidepressants such as Prozac and Paxil was vastly exaggerated when they came on the market. And the results of esketamine trials, which were paid for and carried out by Janssen, were mixed.

In each trial submitted, all patients were started on a new antidepressant drug, and given a course of esketamine treatment or a placebo. In one monthlong study, those on esketamine performed better statistically than those on placebo, reducing scores on a standard, 60-point depression scale by 21 points, compared to 17 points for placebo. But in two others trials, the drug did not statistically outperform placebo treatment. Historically, the F.D.A. has required that a drug succeed in two short-term trials before it is approved; the agency loosened its criteria for esketamine, opting instead to study relapse in people who did well on the drug.

In that trial, Janssen reported that only about one-quarter of subjects relapsed, compared to 45 percent of subjects who received the placebo spray. All the subjects had been given a diagnosis of treatment-resistant depression, or T.R.D., having previously failed multiple courses of drug treatment.

“We’ve had nothing new in 30 years,” said Steven Hollon, a professor of psychiatry and behavior sciences at Vanderbilt University. “So if this drug is an effective way to get a more rapid response in people who are treatment resistant, and we can use it safely, then it could be a godsend.”

One question that will need to be answered is how well esketamine performs in comparison to intravenous ketamine.

Theresa, 57, an adjunct professor of English in New York, who asked that her last name be omitted to protect her privacy, has lived much of her life with deep depression. She tried a course of I.V. generic ketamine last summer, at a local clinic, which typically entails a half-dozen infusions, given over a couple of weeks, for about $500 apiece, with follow-up “booster” treatments as needed.

“I remember floating, I was really high,” she said. “I was tripping on sounds, textures and shapes, that was very much a part of it.”

The first infusion provided no relief, she said. But after the third or fourth, she noticed a satisfying “shift” in her underlying mood. “It’s a hard thing to describe. I was still anxious, but I felt somehow more solid, like something gelled within me, and my husband has noticed it, too.”

Dr. Glen Brooks, the founder and medical director of NY Ketamine Infusions, a clinic in downtown Manhattan, said he has treated some 2,300 people, of all ages, with intravenous ketamine, the generic anesthetic. His clients had received a variety of diagnoses, including post-traumatic stress, anxiety, and obsessive-compulsive disorder, as well as depression.

“What they all have in common is that other medications have failed,” Dr. Brooks, an anesthesiologist, said. “They’re hopeless, and they think, ‘Nothing else has worked, why should this?’” He said that, in his experience, the infusions quickly reduced symptoms for teenagers and young adults, but seemed to be less effective for people over 50.

The data that Janssen presented to the F.D.A. likewise suggested that esketamine was less effective in people aged 65 and older, barely better than placebo treatment.

Ketamine was developed more than five decades ago as a safer alternative to the anesthetic phencyclidine, or PCP, and is used worldwide, in operating rooms, on the battlefield and in pediatric clinics. The World Health Organization has listed ketamine as one of its essential medicines since 1985.

By the 1990s, interest turned to the drug’s potential to combat depression, when a government scientist named Phil Skolnick argued that targeting glutamate pathways — the primary “excitatory,” or neuroactivating, brain processes — could produce antidepressant effects. In 2000, a team of researchers at Yale University and the Connecticut Mental Health Center, led by Dr. Robert M. Berman, reported that doses of ketamine provided quick relief to seven people with depression.

The field took off in 2006, when a team at the National Institute of Mental Health led by Dr. Carlos Zarate Jr. reported that 18 treatment-resistant people who received the drug intravenously reported that their despair lifted within hours.

“What seems remarkable is that the drug also seems to help domains other than depression, like anxiety, suicidal thinking, and anhedonia” — the inability to feel pleasure — said Dr. Zarate, chief of the N.I.M.H.’s experimental therapeutics and pathophysiology branch. “It seems to have more broad effects, on many areas of mood.”

The apparent ability of ketamine to blunt suicidal thinking is particularly compelling, and Janssen is pursuing this indication for esketamine. In jails and psychiatry wards, suicide is an acute risk for people in crisis, and a fast-acting drug could save many lives, doctors said.

For now, no one knows whether esketamine, or any of the other ketamine-based compounds being studied, are any more effective than the generic anesthetic itself — or, for that matter, whether the out-of-body and hallucinatory “side effects” are in fact integral to its antidepressant properties.

“For that, we will need head-to-head studies,” Dr. Zarate said. “And we don’t have those yet.”





Northern Virginia Weight Loss | 703-844-0184 | NOVA Health Recovery |

NOVA Health Recovery | Alexandria, Va 22306 | 703-844-0184 | Call for medical weight loss

FABP2 Gene in focus

FABP2, a gene that appears in both the carbohydrate and saturated fat parts of our reports. This gene creates a protein called Fatty Acid Binding Protein-2, which is found in our small intestines. FABP2 binds to the various different fatty acids, and allows them to be absorbed into the body.

The single nucleotide polymorphism (SNP) that we are interested in occurs when an alanine nucleotide is swapped for a threonine nucleotide; this substitution causes the protein to become more efficient. So efficient, in fact, that it doubles the speed at which we absorb these fats, leading to an increase of fat in the blood stream.

So what effect does this have in the real world? One study, published in 2007 in the American Journal of Clinical Nutrition gives us some idea. The researchers got 122 elderly adults, and put them through a number of different tests to see how they tolerated different types of foods. Those with at least one A allele of FABP2 were less likely to have normal blood glucose levels, both after fasting and after having a big meal. This indicates that they were at risk of developing insulin resistance, which can eventually become type-II diabetes. If we know that A allele carriers are more likely to develop type-II diabetes, then we can give them dietary advice which might help to reduce their risk, such as consuming a diet lower in simple and refined carbohydrates.

We’ve looked at the effects of FABP2 on our carbohydrate sensitivity, but how about saturated fats? A meta-analysis published in 2010 gives us an insight into this. Meta-analyses are useful tools for researchers and medical professionals, as they analyse the data of existing research in a particular area, and summarise it to give us a better idea of the current evidence in that field. The results from this meta-analysis looked at 30 different studies, with over 14,000 subjects. It found that A-allele carriers of FABP2 were significantly more likely to have higher concentrations of total- and LDL-cholesterol (LDL cholesterol is commonly known as “bad” cholesterol), and lower levels of HDL-cholesterol (“good” cholesterol) – showing quite nicely that this gene influences how much fat we should have in our diet.

We use FABP2 alongside a number of other genes to give each person an idea of their individual response to both carbohydrates and fats, information that we can then use to determine the optimal diet type for weight management. The below table summarises the main findings regarding FABP2:

FABP2 GenotypeFindings
GGThis genotype is not associated with an increased sensitivity to saturated fats or refined carbohydrates.
GAA single copy of the A allele is associated with a moderately increased sensitivity to saturated fats and refined carbohydrates.
AATwo copies of the A allele of FABP2 means that this genotype is associated with a significantly increased sensitivity to both saturated fats and refined carbohydrates.

DNA Fit blog

DNA Fit blog

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Ketamine Virginia Link

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Ketamine Virginia Link

Ketamine Works as a Fast-Acting Antidepressant, But the Full Effects Are Still Unknown

Ketamine Works as a Fast-Acting Antidepressant, But the Full Effects Are Still Unknown

etamine leads something of a double life, straddling the line between medical science and party drug. Since it’s invention in the early 1960s, ketamine has enjoyed a quiet existence as a veterinary and pediatric anesthetic given in high doses. But in a second, wilder life, ketamine’s effects at lower doses—a profound sense of dissociation from self and body—became an illicit favorite among psychedelic enthusiasts. Pioneering neuroscientist John Lilly, who famously attempted to facilitate communication between humans and dolphins, used the drug in the late 1970s during experiments in sensory deprivation tanks. By the 1990s, the drug had made its way to the dance floor as “special K.”

More recently, ketamine has taken on a third, wholly unexpected role. Since the early 2000s, the drug has been studied as a uniquely powerful medication for treating severe depression and obsessive-compulsive disorder (OCD). When given as an intravenous infusion, ketamine can lift symptoms of depression and OCD from patients who fail to respond to common antidepressants like Prozac and even resist treatments like electroconvulsive therapy (ECT).

Exactly how ketamine produces antidepressant effects remains unclear, however. Antidepressants like Prozac are Serotonin Reuptake Inhibitors (SSRIs) that increase levels of the neurotransmitter serotonin in the brain, which is believed to boost mood. Ketamine’s main mechanism of action to produce dissociative anesthetic effects, on the other hand, depends on another neurotransmitter, glutamate.

“The prevailing hypothesis for ketamine’s antidepressant effect is that it blocks a receptor (or docking port) for glutamate,” says Carolyn Rodriguez, a professor of psychiatry at Stanford who has conducted some of the pioneering research into ketamine as an OCD treatment.

However, new research suggests that ketamine’s influence on glutamate receptors, and specifically the NMDA receptor, may not be the sole cause of its antidepressant effects. According to a recent study in the American Journal of Psychiatry by Rodriguez and her Stanford colleagues, ketamine might also activate a third system in the brain: opioid receptors.

Ketamine is known to bind weakly to the mu opioid receptor, acting as an agonist to produce a physiological response at the same site in the brain where narcotics like morphine exert their influence. It’s also known that opioids can have antidepressant effects, says Alan Schatzberg, a professor of psychiatry at Stanford and co-author of the new study.

It never made sense to Schatzberg that ketamine’s antidepressant effects were a result of blocking the glutamate receptors, as attempts to use other glutamate-blocking drugs as antidepressants have largely failed. The Stanford psychiatrist, who has spent his career studying depression, wondered if researchers were unknowingly activating opioid receptors with ketamine.

“You could test this by using an antagonist of the opioid system to see if you blocked the effect in people who are ketamine responders,” he says. “And that’s what we did.”

The researchers enlisted 12 subjects with treatment-resistant depression and gave them either an infusion of ketamine preceded by a placebo, or ketamine preceded by a dose of naltrexone, an opioid receptor blocker. Of those, seven subjects responded to the ketamine with placebo, “and it was very dramatic,” Schatzberg says, with depression lifting by the next day. “But in the other condition, they showed no effect,” suggesting it was the opioid receptor activity, not blocking glutamate receptors, that was responsible.

While opioid blockers prevented ketamine from activating the associated receptors, it did not block the drugs dissociative effects, suggesting dissociation alone won’t affect depression. “It’s not that, ‘hey, we’ll get you a little weird and you’ll get the effect,’” Schatzberg says.

The appeal of ketamine’s use as an antidepressant is clear enough. While more typical antidepressants may require six to eight weeks to produce benefits, ketamine works within hours.

“Our patients are asked to hang in there until the medication and talk therapy takes effect,” says Carlos Zarate, chief of the experimental therapeutics and pathophysiology branch of the National Institute of Mental Health (NIMH) who was not associated with the new study. While waiting for traditional treatments to kick in, patients “may lose their friends or even attempt suicide.”

But the study linking ketamine to opioid activity means an extra dose of caution is required. While ketamine acts quickly, the anti-depressive effects of the drug only last for a few days to a week, meaning repeat doses would be needed in practice. Researchers and clinicians should consider the risk of addiction in long-term use, Schatzberg says. “You’re going to eventually get into some form of tolerance I think, and that’s not good.”

However, the new finding is based on just seven subjects, and it still needs to be replicated by other scientists, says Yale professor of psychiatry Greg Sanacora, who was not involved in the new study. And even if the trial is replicated, it would not prove ketamine’s opioid activity is responsible for its antidepressant effects.

“It doesn’t show that at all,” says Sanacora, who studies glutamate, mood disorders and ketamine. “It shows that the opioid system needs to be functioning in order to get this response.”

Sanacora compares the new study to using antibiotics to treat an ear infection. If you administered an additional drug that blocks absorption of antibiotics in the stomach, you would block treatment of the ear infection, but you wouldn’t conclude that antibiotics fight ear infections through stomach absorption—you just need a normally functioning stomach to allow the antibiotic to do its job. Similarly, opioid receptors might need to be functioning normally for ketamine to produce antidepressant effects, even if opioid activity is not directly responsible for those effects.

Complicating matters further, placebos often cause patients to experience less pain, but opioid blockers like naltrexone have been shown to prevent this response, according to Sanacora. It could be, he suggests, that all the apparatus of the clinic—the nursing staff, the equipment—exerted a placebo effect that is mediated by the brain’s opioid system, and the patients who received naltrexone simply did not respond to that placebo effect

“That’s a very important and powerful tool that is in all of medicine, not just in psychiatry,” Sanacora says. “And we know that the opiate system is involved, to some extent, in that type of response.”

It’s also possible, the researchers note in the paper, that ketamine’s action at the glutamate receptor is still important. “Ketamine acts in three distinct phases—rapid effects, sustained effects and return to baseline,” Rodriguez says. Opioid signaling may turn out to mediate ketamine’s rapid effects, while “the glutamate system may be responsible for the sustaining effects after ketamine is metabolized.”

One interpretation is that ketamine blocks glutamate receptors on neurons that are inhibitory, meaning they signal other neurons to fire fewer signals. By blocking these neurons from firing, ketamine may enhance glutamate activity in the rest of the brain, producing anti-depressive effects that persist after the opioid activity dies down.

“The reality is it’s in a gray zone,” Sanacora says. “This is just one small piece of a very large puzzle or concern that we really need to look at the data in total.”

That data is forthcoming. Results from a Janssen Pharmaceuticals clinical trial using esketamine, an isomer of ketamine, and involving hundreds of subjects will soon become public, according to Sanacora, who has consulted for the company. And at NIMH, Zarate and colleagues are studying hydroxynorketamine, a metabolite of ketamine that may provide the same benefits but without the dissociative side effects

Ketamine Works as a Fast-Acting Antidepressant, But the Full Effects Are Still Unknown

A new study suggests that ketamine activates the brain’s opioid receptors, complicating its use to treat clinical depression

Ketamine Syringe
Ketamine syringe, 10mg held by a healthcare professional. (Peter Cripps / Alamy Stock Photo)

By Jon KelveySEPTEMBER 11, 2018777110231.1K

Ketamine leads something of a double life, straddling the line between medical science and party drug. Since it’s invention in the early 1960s, ketamine has enjoyed a quiet existence as a veterinary and pediatric anesthetic given in high doses. But in a second, wilder life, ketamine’s effects at lower doses—a profound sense of dissociation from self and body—became an illicit favorite among psychedelic enthusiasts. Pioneering neuroscientist John Lilly, who famously attempted to facilitate communication between humans and dolphins, used the drug in the late 1970s during experiments in sensory deprivation tanks. By the 1990s, the drug had made its way to the dance floor as “special K.”

More recently, ketamine has taken on a third, wholly unexpected role. Since the early 2000s, the drug has been studied as a uniquely powerful medication for treating severe depression and obsessive-compulsive disorder (OCD). When given as an intravenous infusion, ketamine can lift symptoms of depression and OCD from patients who fail to respond to common antidepressants like Prozac and even resist treatments like electroconvulsive therapy (ECT).

Exactly how ketamine produces antidepressant effects remains unclear, however. Antidepressants like Prozac are Serotonin Reuptake Inhibitors (SSRIs) that increase levels of the neurotransmitter serotonin in the brain, which is believed to boost mood. Ketamine’s main mechanism of action to produce dissociative anesthetic effects, on the other hand, depends on another neurotransmitter, glutamate.

“The prevailing hypothesis for ketamine’s antidepressant effect is that it blocks a receptor (or docking port) for glutamate,” says Carolyn Rodriguez, a professor of psychiatry at Stanford who has conducted some of the pioneering research into ketamine as an OCD treatment.

However, new research suggests that ketamine’s influence on glutamate receptors, and specifically the NMDA receptor, may not be the sole cause of its antidepressant effects. According to a recent study in the American Journal of Psychiatry by Rodriguez and her Stanford colleagues, ketamine might also activate a third system in the brain: opioid receptors.

Ketamine is known to bind weakly to the mu opioid receptor, acting as an agonist to produce a physiological response at the same site in the brain where narcotics like morphine exert their influence. It’s also known that opioids can have antidepressant effects, says Alan Schatzberg, a professor of psychiatry at Stanford and co-author of the new study.

It never made sense to Schatzberg that ketamine’s antidepressant effects were a result of blocking the glutamate receptors, as attempts to use other glutamate-blocking drugs as antidepressants have largely failed. The Stanford psychiatrist, who has spent his career studying depression, wondered if researchers were unknowingly activating opioid receptors with ketamine.

“You could test this by using an antagonist of the opioid system to see if you blocked the effect in people who are ketamine responders,” he says. “And that’s what we did.”

The researchers enlisted 12 subjects with treatment-resistant depression and gave them either an infusion of ketamine preceded by a placebo, or ketamine preceded by a dose of naltrexone, an opioid receptor blocker. Of those, seven subjects responded to the ketamine with placebo, “and it was very dramatic,” Schatzberg says, with depression lifting by the next day. “But in the other condition, they showed no effect,” suggesting it was the opioid receptor activity, not blocking glutamate receptors, that was responsible.

While opioid blockers prevented ketamine from activating the associated receptors, it did not block the drugs dissociative effects, suggesting dissociation alone won’t affect depression. “It’s not that, ‘hey, we’ll get you a little weird and you’ll get the effect,’” Schatzberg says.

The appeal of ketamine’s use as an antidepressant is clear enough. While more typical antidepressants may require six to eight weeks to produce benefits, ketamine works within hours.

“Our patients are asked to hang in there until the medication and talk therapy takes effect,” says Carlos Zarate, chief of the experimental therapeutics and pathophysiology branch of the National Institute of Mental Health (NIMH) who was not associated with the new study. While waiting for traditional treatments to kick in, patients “may lose their friends or even attempt suicide.”

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A treatment that works within 24 hours? “That’s huge.”

A vial of ketamine. The drug is used primarily as an anesthetic but is gaining popularity as an effective antidepressant.
A vial of ketamine. The drug is used primarily as an anesthetic but is gaining popularity as an effective antidepressant. (Wikimedia Commons)

But the study linking ketamine to opioid activity means an extra dose of caution is required. While ketamine acts quickly, the anti-depressive effects of the drug only last for a few days to a week, meaning repeat doses would be needed in practice. Researchers and clinicians should consider the risk of addiction in long-term use, Schatzberg says. “You’re going to eventually get into some form of tolerance I think, and that’s not good.”

However, the new finding is based on just seven subjects, and it still needs to be replicated by other scientists, says Yale professor of psychiatry Greg Sanacora, who was not involved in the new study. And even if the trial is replicated, it would not prove ketamine’s opioid activity is responsible for its antidepressant effects.

“It doesn’t show that at all,” says Sanacora, who studies glutamate, mood disorders and ketamine. “It shows that the opioid system needs to be functioning in order to get this response.”

Sanacora compares the new study to using antibiotics to treat an ear infection. If you administered an additional drug that blocks absorption of antibiotics in the stomach, you would block treatment of the ear infection, but you wouldn’t conclude that antibiotics fight ear infections through stomach absorption—you just need a normally functioning stomach to allow the antibiotic to do its job. Similarly, opioid receptors might need to be functioning normally for ketamine to produce antidepressant effects, even if opioid activity is not directly responsible for those effects.

Complicating matters further, placebos often cause patients to experience less pain, but opioid blockers like naltrexone have been shown to prevent this response, according to Sanacora. It could be, he suggests, that all the apparatus of the clinic—the nursing staff, the equipment—exerted a placebo effect that is mediated by the brain’s opioid system, and the patients who received naltrexone simply did not respond to that placebo effect.

“That’s a very important and powerful tool that is in all of medicine, not just in psychiatry,” Sanacora says. “And we know that the opiate system is involved, to some extent, in that type of response.”

It’s also possible, the researchers note in the paper, that ketamine’s action at the glutamate receptor is still important. “Ketamine acts in three distinct phases—rapid effects, sustained effects and return to baseline,” Rodriguez says. Opioid signaling may turn out to mediate ketamine’s rapid effects, while “the glutamate system may be responsible for the sustaining effects after ketamine is metabolized.”

One interpretation is that ketamine blocks glutamate receptors on neurons that are inhibitory, meaning they signal other neurons to fire fewer signals. By blocking these neurons from firing, ketamine may enhance glutamate activity in the rest of the brain, producing anti-depressive effects that persist after the opioid activity dies down.

“The reality is it’s in a gray zone,” Sanacora says. “This is just one small piece of a very large puzzle or concern that we really need to look at the data in total.”

That data is forthcoming. Results from a Janssen Pharmaceuticals clinical trial using esketamine, an isomer of ketamine, and involving hundreds of subjects will soon become public, according to Sanacora, who has consulted for the company. And at NIMH, Zarate and colleagues are studying hydroxynorketamine, a metabolite of ketamine that may provide the same benefits but without the dissociative side effects.

The ultimate goal of all this research is to find a ketamine-like drug with fewer liabilities, and that aim is bringing researchers back to the fundamentals of science.

“For me, one of the exciting parts of this study is that it suggests that ketamine’s mechanism is complicated, it acts on different receptors beyond glutamate and is the start of this exciting dialogue,” Rodriguez says. “Sometimes great science raises more questions than answers.”



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A depression drug that’s been called ‘the most important discovery in half a century’ just got a big step closer to FDA approval

  • A first-of-its-kind treatment for depression got a big nod on Tuesday from a group of scientists convened by the US Food and Drug Administration.
  • Experts concluded that the drug, called esketamine and inspired by ketamine, is safe and effective and said its benefits outweighed its risks.
  • Their input will play a key role in the FDA’s final approval decision, expected in March.
  • If given the official green light, the drug would be the first novel therapeutic for depression in 35 years.

A drug inspired by ketamine, which has been called “the most important discovery in half a century,” is on the cusp of becoming the first new kind of depression medication in 35 years.

Called esketamine and developed by Johnson & Johnson, the drug is a nasal spray designed to treat severe forms of depression that don’t respond to other medications. It’s the chemical mirror image of ketamine and thought to have slightly fewer side effects than the original compound.

On Tuesday, a panel of experts convened by the Food and Drug Administration voted 14-2 in favor of the drug’s effectiveness and 15-2 in favor of its safety. Their recommendation will play a key role in the FDA’s approval decision, expected in March.

Additionally, they voted 14-2 that the drug’s benefits outweighed its risks.

“I think there’s substantial evidence that this could be a game-changer,” Steven Meisel, a system director of medication safety with Fairview Health Services who was one of the panel’s 17 voting members, said on Tuesday.

If the FDA approves the drug, it would be the first federally approved depression drug in nearly four decades to work differently than depression medications on the market.

That’s a significant milestone. Depression is the world’s leading cause of poor health and disability, and as many as one in threepatients don’t get relief from existing antidepressants.

Analysts are hopeful that Johnson & Johnson’s new drug could help.

“Ultimately, we think [esketamine’s] risk-benefit profile favors approval, especially in a disease paradigm where little options are available,” Carter Gould, the executive director of biotech equity research at UBS, wrote in a note circulated last week.

The emerging science on ketamine

columbia midtown ketamine clinic inside
A growing list of academic medical centers, including Columbia University, offer ketamine to patients with severe depression.

Whether it’s Abilify or Zoloft, almost all antidepressants work by plugging up the places where our brain takes up serotonin, a chemical messenger that plays a key role in our mood.

Ketamine appears to engage a different part of the brain than traditional antidepressants, which is part of the reason it’s been called “the most important discovery in half a century” for mental illness.

The drug’s apparent rapid-fire effects may be especially useful for staunching suicidal thinking in people who are considering taking their own lives, experts say. Ketamine also has long been used to prevent pain, which suggests to clinicians that it’s relatively safe.

“There is nothing approved that gets patients better this fast,” Walter S. Dunn, a psychiatrist and assistant clinical professor at the University of California Los Angeles who was also one of the panel’s voting members, said on Tuesday.

But right now, ketamine is neither cheap nor quick to administer. Because it’s given through an IV drip, the process can take 45 minutes to two hours. Each session costs $500 to $750 and is not covered by insurance, because ketamine is approved in the US only for use as an anesthetic. People given ketamine for depression are typically advised to get eight to 12 sessions, bringing the total cost toas much as $9,000.

Ketamine and esketamine also have some negative side effects. The most troublesome, according to analysts and scientists, is the drugs’ tendency to produce what’s known as dissociative — or “out of body” — experiences.

Experts worry that some patients could react negatively to the experience and then avoid the drug, or react positively and want to repeatedly use it, potentially leading to a drug-use disorder. Experts on the FDA panel said no misuse or abuse was seen in Johnson & Johnson’s clinical trials, however, adding that they considered the risk of abuse among adults to be low.

Read more: A ‘party drug’ with potential to be the next blockbuster antidepressant is edging closer to the mainstream, but it could set you back $9,000

Johnson & Johnson’s nasal spray for depression

Johnson & Johnson’s formulation of esketamine is designed to be taken as a nasal spray alongside a traditional antidepressant, reducing the time required to administer the treatment and potentially making it less expensive. (The company has not said how much the drug could cost.)

The company’s clinical-trial data suggests that the drug is fairly safe and well tolerated but still has some negative side effects.

More than a third of patients in two of Johnson & Johnson’s last-phase clinical trials reported dissociation. To address that, researchers say, the drug should be given in the presence of a clinician who can monitor the person for at least two hours after treatment. Roughly a third of patients in the trials reported dizziness, sedation, or nausea.

Also, because the studies focused on people with severe forms of depression that don’t respond to other medications, suicide was a known risk among the participants. In Johnson & Johnson’s trials, at least three patients died by suicide. On Tuesday, experts said these deaths were not likely a direct result of esketamine — if anything, they could have occurred because it didn’t work well enough, said Qi Chen, an FDA safety reviewer on the panel.

Julie Zito, a pharmacy professor at the University of Maryland who was one of two people who voted against esketamine’s effectiveness, said she didn’t see enough evidence of substantial improvement in mood among the clinical-trial participants.

Other researchers on the FDA panel said the drug still appeared to be more convenient than available antidepressants and the IV version of esketamine because the nasal spray doesn’t require an IV and could be given as frequently as once a week.

Esketamine also appeared to work better than a placebo in people with severe forms of depression over a month. However, the latest clinical trial— one of five studies presented to the FDA — was not able to show that the drug was statistically superior to a placebo. That’s a key finding that other trials appeared to support.

For a study published last May, Johnson & Johnson’s neuroscience partner, Janssen Research, had nearly 240 adults with severe depression take a traditional antidepressant plus a nasal spray for a month. Half got a spray with Johnson & Johnson’s drug, while the other half got a placebo spray. Those results were promising: The people who got the esketamine spray saw significantly better improvements in their depressive symptoms than those who got the placebo.

The month before, researchers did a small, daylong version of the study and came away with similar results. But the latest study, of nearly 350 adults, did not show numbers statistically significant enough to bolster the other findings.

Nevertheless, most of the experts on the FDA-assembled committee said they considered the drug an effective treatment for severe depression. Some said the latest study still suggested positive results even though the findings didn’t reach statistical significance.

“I was persuaded not only by the two positive trials but even by the partial evidence in the third trial that was at least pointing in the same direction,” Wilson Compton, the deputy director of the National Institute on Drug Abuse with the National Institutes of Health, said on Tuesday.



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Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate

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Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate

A version of the club drug is expected to be approved for depression in March. Researchers think it could help treat suicidal thinking.

Joe Wright has no doubt that ketamine saved his life. A 34-year-old high school teacher who writes poetry every day on a typewriter, Wright was plagued by suicidal impulses for years. The thoughts started coming on when he was a high schooler himself, on Staten Island, N.Y., and intensified during his first year of college. “It was an internal monologue, emphatic on how pointless it is to exist,” he says. “It’s like being ambushed by your own brain.”

He first tried to kill himself by swallowing a bottle of sleeping pills the summer after his sophomore year. Years of treatment with Prozac, Zoloft, Wellbutrin, and other antidepressants followed, but the desire for an end was never fully resolved. He started cutting himself on his arms and legs with a pencil-sharpener blade. Sometimes he’d burn himself with cigarettes. He remembers few details about his second and third suicide attempts. They were halfhearted; he drank himself into a stupor and once added Xanax into the mix.

Wright decided to try again in 2016, this time using a cocktail of drugs he’d ground into a powder. As he tells the story now, he was preparing to mix the powder into water and drink it when his dog jumped onto his lap. Suddenly he had a moment of clarity that shocked him into action. He started doing research and came upon a Columbia University study of a pharmaceutical treatment for severe depression and suicidality. It involved an infusion of ketamine, a decades-old anesthetic that’s also an infamous party drug. He immediately volunteered.

His first—and only—ketamine infusion made him feel dreamlike, goofy, and euphoric. He almost immediately started feeling more hopeful about life. He was more receptive to therapy. Less than a year later, he married. Today he says his dark moods are remote and manageable. Suicidal thoughts are largely gone. “If they had told me how much it would affect me, I wouldn’t have believed it,” Wright says. “It is unconscionable that it is not already approved for suicidal patients.”

The reasons it isn’t aren’t strictly medical. Over the past three decades, pharmaceutical companies have conducted hundreds of trials for at least 10 antidepressants to treat severe PMS, social anxiety disorder, and any number of conditions. What they’ve almost never done is test their drugs on the sickest people, those on the verge of suicide. There are ethical considerations: Doctors don’t want to give a placebo to a person who’s about to kill himself. And reputational concerns: A suicide in a drug trial could hurt a medication’s sales prospects.

The risk-benefit calculation has changed amid the suicide epidemic in the U.S. From 1999 to 2016, the rate of suicides increased by 30 percent. It’s now the second-leading cause of death for 10- to 34-year-olds, behind accidents. (Globally the opposite is true: Suicide is decreasing.) Growing economic disparity, returning veterans traumatized by war, the opioid crisis, easy access to guns—these have all been cited as reasons for the rise in America. There’s been no breakthrough in easing any of these circumstances.

But there is, finally, a serious quest for a suicide cure. Ketamine is at the center, and crucially the pharmaceutical industry now sees a path. The first ketamine-based drug, from Johnson & Johnson, could be approved for treatment-resistant depression by March and suicidal thinking within two years. Allergan Plc is not far behind in developing its own fast-acting antidepressant that could help suicidal patients. How this happened is one of the most hopeful tales of scientific research in recent memory.

relates to Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate
Dennis Charney at Mount Sinai.PHOTOGRAPHER: MAX AGUILERA-HELLWEG FOR BLOOMBERG BUSINESSWEEK

Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai in New York, works from an office filled with family pictures, diplomas, and awards from a long career in research. One thing on the wall is different from the rest: a patent for the use of a nasal-spray form of ketamine as a treatment for suicidal patients. The story of the drug is in some ways the story of Charney’s career.

In the 1990s he was a psychiatry professor, mentoring then associate professor John Krystal at Yale and trying to figure out how a deficit of serotonin played into depression. Back then, depression research was all about serotonin. The 1987 approval of Prozac, the first selective serotonin reuptake inhibitor, or SSRI, ushered in an era of what people in the industry call me-too drug development, research that seeks to improve on existing medicines rather than exploring new approaches. Within this narrow range, pharmaceutical companies churned out blockbuster after blockbuster. One in eight Americans age 12 and older reported using antidepressants within the past month, according to a survey conducted from 2011 to 2014 by the U.S. Centers for Disease Control and Prevention.

Charney was a depression guy; Krystal was interested in schizophrenia. Their curiosity led them to the same place: the glutamate system, what Krystal calls the “main information highway of the higher brain.” (Glutamate is an excitatory neurotransmitter, which helps brain cells communicate. It’s considered crucial in learning and memory formation.) They had already used ketamine to temporarily produce schizophrenia-like symptoms, to better understand glutamate’s role in that condition. In the mid-1990s they decided to conduct a single-dose study of ketamine on nine patients (two ultimately dropped out) at the Yale-affiliated VA Connecticut Healthcare System in West Haven to see how depressed people would react to the drug.

“If we had done the typical thing … we would have completely missed the antidepressant effect”

Outside the field of anesthesiology, ketamine is known, if it’s known at all, for its abuse potential. Street users sometimes take doses large enough to enter what’s known as a “K hole,” a state in which they’re unable to interact with the world around them. Over the course of a day, those recreational doses can be as much as 100 times greater than the tiny amount Charney and Krystal were planning to give to patients. Nonetheless, they decided to monitor patients for 72 hours—well beyond the two hours that ketamine produces obvious behavioral effects—just to be careful not to miss any negative effects that might crop up. “If we had done the typical thing that we do with these drug tests,” Krystal says, “we would have completely missed the antidepressant effect of ketamine.”

Checking on patients four hours after the drug had been administered, the researchers saw something unexpected. “To our surprise,” Charney says, “the patients started saying they were better, they were better in a few hours.” This was unheard of. Antidepressants are known for taking weeks or months to work, and about a third of patients aren’t sufficiently helped by the drugs. “We were shocked,” says Krystal, who now chairs the Yale psychiatry department. “We didn’t submit the results for publication for several years.”

When Charney and Krystal did publish their findings, in 2000, they attracted almost no notice. Perhaps that was because the trial was so small and the results were almost too good to be true. Or maybe it was ketamine’s reputation as an illicit drug. Or the side effects, which have always been problematic: Ketamine can cause patients to disassociate, meaning they enter a state in which they feel as if their mind and body aren’t connected.

But probably none of these factors mattered as much as the bald economic reality. The pharmaceutical industry is not in the business of spending hundreds of millions of dollars to do large-scale studies of an old, cheap drug like ketamine. Originally developed as a safer alternative to the anesthetic phencyclidine, better known as PCP or angel dust, ketamine has been approved since 1970. There’s rarely profit in developing a medication that’s been off patent a long time, even if scientists find an entirely new use for it.

Somehow, even with all of this baggage, research into ketamine inched forward. The small study that almost wasn’t published has now been cited more than 2,000 times.

relates to Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate
John Mann in his office at Columbia’s New York State Psychiatric Institute. 

Suicide is described in medicine as resulting from a range of mental disorders and hardships—a tragedy with many possible roots. Conditions such as severe depression, bipolar disorder, and schizophrenia are known risk factors. Childhood trauma or abuse may also be a contributor, and there may be genetic risk factors as well.

From these facts, John Mann, an Australian-born psychiatrist with a doctorate in neurochemistry, made a leap. If suicide has many causes, he hypothesized, then all suicidal brains might have certain characteristics in common. He’s since done some of the most high-profile work to illuminate what researchers call the biology of suicide. The phrase itself represents a bold idea—that there’s an underlying physiological susceptibility to suicide, apart from depression or another psychiatric disorder.

Mann moved to New York in 1978, and in 1982, at Cornell University, he started collecting the brains of people who’d killed themselves. He recruited Victoria Arango, now a leading expert in the field of suicide biology. The practice of studying postmortem brain tissue had largely fallen out of favor, and Mann wanted to reboot it. “He was very proud to take me to the freezer,” Arango says of the day Mann introduced her to the brain collection, which then numbered about 15. “I said, ‘What am I supposed to do with this?’ ”

relates to Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate
Some of Mann’s brain collection. 

They took the work, and the brains, first to the University of Pittsburgh, and then, in 1994, to Columbia. They’ve now amassed a collection of some 1,000 human brains—some from suicide victims, the others, control brains—filed neatly in freezers kept at –112F. The small Balkan country of Macedonia contributes the newest brains, thanks to a Columbia faculty member from there who helped arrange it. The Macedonian brains are frozen immediately after being removed and flown in trunks, chaperoned, some 4,700 miles to end up in shoe-box-size, QR-coded black boxes. Inside are dissected sections of pink tissue in plastic bags notated with markers: right side, left side, date of collection.

In the early 1990s, Mann and Arango discovered that depressed patients who killed themselves have subtle alterations in serotonin in certain regions of the brain. Mann remembers sitting with Arango and neurophysiologist Mark Underwood, her husband and longtime research partner, and analyzing the parts of the brain affected by the deficit. They struggled to make sense of it, until it dawned on them that these were the same brain regions described in a famous psychiatric case study. In 1848, Phineas Gage, an American railroad worker, was impaled through the skull by a 43-inch-long tamping iron when the explosives he was working with went off prematurely. He survived, but his personality was permanently altered. In a paper titled “Recovery From the Passage of an Iron Bar Through the Head,” his doctor wrote that Gage’s “animal propensities” had emerged and described him as using the “grossest profanity.” Modern research has shown that the tamping iron destroyed key areas of the brain involved in inhibition—the same areas that were altered in the depressed patients who’d committed suicide. For the group, this was a clue that the differences in the brain of suicidal patients were anatomically important.

relates to Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate
Columbia’s Victoria Arango. 

“Most people inhibit suicide. They find a reason not to do it,” Underwood says. Thanks to subtle changes in the part of the brain that might normally control inhibition and top-down control, people who kill themselves “don’t find a reason not to do it,” he says.

About eight years ago, Mann saw ketamine research taking off in other corners of the scientific world and added the drug to his own work. In one trial, his group found that ketamine treatment could ease suicidal thoughts in 24 hours more effectively than a control drug. Crucially, they found that the antisuicidal effects of ketamine were to some extent independent of the antidepressant effect of the drug, which helped support their thesis that suicidal impulses aren’t necessarily just a byproduct of depression. It was this study, led by Michael Grunebaum, a colleague of Mann’s, that made a believer of Joe Wright.

“It’s like you have 50 pounds on your shoulders, and the ketamine takes 40 pounds off”

In 2000, the National Institutes of Health hired Charney to run both mood disorder and experimental drug research. It was the perfect place for him to forge ahead with ketamine. There he did the work to replicate what he and his colleagues at Yale had discovered. In a study published in 2006, led by researcher Carlos Zarate Jr., who now oversees NIH studies of ketamine and suicidality, an NIH team found that patients had “robust and rapid antidepressant effects” from a single dose of the drug within two hours. “We could not believe it. In the first few subjects we were like, ‘Oh, you can always find one patient or two who gets better,’ ” Zarate recalls.

In a 2009 study done at Mount Sinai, patients suffering from treatment-resistant depression showed rapid improvement in suicidal thinking within 24 hours. The next year, Zarate’s group demonstrated antisuicidal effects within 40 minutes. “That you could replicate the findings, the rapid findings, was quite eerie,” Zarate says.

Finally ketamine crossed back into commercial drug development. In 2009, Johnson & Johnson lured away Husseini Manji, a prominent NIH researcher who’d worked on the drug, to run its neuroscience division. J&J didn’t hire him explicitly to develop ketamine into a new pharmaceutical, but a few years into his tenure, Manji decided to look into it. This time it would come in a nasal-spray form of esketamine, a close chemical cousin. That would allow for patent protection. Further, the nasal spray removes some of the challenges that an IV form of the drug would present. Psychiatrists, for one thing, aren’t typically equipped to administer IV drugs in their offices.

While these wheels were slowly turning, some doctors—mostly psychiatrists and anesthesiologists—took action. Around 2012 they started opening ketamine clinics. Dozens have now popped up in major metropolitan areas. Insurance typically won’t touch it, but at these centers people can pay about $500 for an infusion of the drug. It was at one time a cultural phenomenon—a 2015 Bloomberg Businessweek story called it “the club drug cure.” Since then, the sense of novelty has dissipated. In September the American Society of Ketamine Physicians convened its first medical meeting about the unconventional use of the drug.

“You are literally saving lives,” Steven Mandel, an anesthesiologist-turned-ketamine provider, told a room of about 100 people, mostly doctors and nurse practitioners, who gathered in Austin to hear him and other early adopters talk about how they use the drug. Sporadic cheers interrupted the speakers as they presented anecdotes about its effectiveness.

There were also issues to address. A consensus statementin JAMA Psychiatry published in 2017 said there was an “urgent need for some guidance” on ketamine use. The authors were particularly concerned with the lack of data about the safety of prolonged use of the drug in people with mood disorders, citing “major gaps” in the medical community’s knowledge about its long-term impact.

The context for the off-label use of ketamine is a shrinking landscape for psychiatry treatment. An effort to deinstitutionalize the U.S. mental health system, which took hold in the 1960s, has almost resulted in the disappearance of psychiatric hospitals and even psychiatric beds within general hospitals. There were 37,679 psychiatric beds in state hospitals in 2016, down from 558,922 in 1955, according to the Treatment Advocacy Center. Today a person is often discharged from a hospital within days of a suicide attempt, setting up a risky situation in which someone who may not have fully recovered ends up at home with a bunch of antidepressants that could take weeks to lift his mood, if they work at all.

A ketamine clinic can be the way out of this scenario—for people with access and means. For Dana Manning, a 53-year-old Maine resident who suffers from bipolar disorder, $500 is out of reach. “I want to die every day,” she says.

After trying to end her life in 2003 by overdosing on a cocktail of drugs including Xanax and Percocet, Manning tried virtually every drug approved for bipolar disorder. None stopped the mood swings. In 2010 the depression came back so intensely that she could barely get out of bed and had to quit her job as a medical records specialist. Electroconvulsive therapy, the last-ditch treatment for depressed patients who don’t respond to drugs, didn’t help.

Her psychiatrist went deep into the medical literature to find options and finally suggested ketamine. He was even able to get the state Medicaid program to cover it, she says. She received a total of four weekly infusions before she moved to Pennsylvania, where there were more family members nearby to care for her.

The first several weeks following her ketamine regimen were “the only time I can say I have felt normal” in 15 years, she says. “It’s like you have 50 pounds on your shoulders, and the ketamine takes 40 pounds off.”

She’s now back in Maine, and the depression has returned. Her current Medicare insurance won’t cover ketamine. She lives on $1,300 a month in disability income. “Knowing it is there and I can’t have it is beyond frustrating,” she says.

relates to Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate
Mark Underwood at the New York State Psychiatric Institute. 

Ketamine is considered a “dirty” drug by scientists—it affects so many pathways and systems in the brain at the same time that it’s hard to single out the exact reason it works in the patients it does help. That’s one reason researchers continue to look for better versions of the drug. Another, of course, is that new versions are patentable. Should Johnson & Johnson’s esketamine hit the market, the ketamine pioneers and their research institutions stand to benefit. Yale’s Krystal, NIH’s Zarate, and Sinai’s Charney, all of whom are on the patent on Charney’s wall, will collect royalties based on the drug’s sales. J&J hasn’t said anything about potential pricing, but there’s every reason to believe the biggest breakthrough in depression treatment since Prozac will be expensive.

The company’s initial esketamine study in suicidal patients involved 68 people at high risk. To avoid concerns about using placebos on actively suicidal subjects, everyone received antidepressants and other standard treatments. About 40 percent of those who received esketamine were deemed no longer at risk of killing themselves within 24 hours. Two much larger trials are under way.

When Johnson & Johnson unveiled data from its esketamine study in treatment-resistant depression at the American Psychiatric Association meeting in May, the presentation was jammed. Esketamine could become the first-ever rapid-acting antidepressant, and physicians and investors are clamoring for any information about how it works. The results in suicidal patients should come later this year and could pave the way for a Food and Drug Administration filing for use in suicidal depressed patients in 2020. Allergan expects to have results from its suicide study next year, too.

“The truth is, what everybody cares about is, do they decrease suicide attempts?” says Gregory Simon, a psychiatrist and mental health researcher at Kaiser Permanente Washington Health Research Institute. “That is an incredibly important question that we hope to be able to answer, and we are planning for when these treatments become available.”

Exactly how ketamine and its cousin esketamine work is still the subject of intense debate. In essence, the drugs appear to provide a quick molecular reset button for brains impaired by stress or depression. Both ketamine and esketamine release a burst of glutamate. This, in turn, may trigger the growth of synapses, or neural connections, in brain areas that may play a role in mood and the ability to feel pleasure. It’s possible the drug works to prevent suicide by boosting those circuits while also reestablishing some of the inhibition needed to prevent a person from killing himself. “We certainly think that esketamine is working exactly on the circuitry of depression,” Manji says. “Are we homing in exactly on where suicidal ideation resides?” His former colleagues at NIH are trying to find that spot in the brain as well. Using polysomnography—sleep tests in which patients have nodes connected to various parts of their head to monitor brain activity—as well as MRIs and positron emission tomography, or PET scans, researchers can see how a patient’s brain responds to ketamine, to better understand exactly what it’s doing to quash suicidal thinking.

Concerns about the side effects of ketamine-style drugs linger. Some patients taking esketamine have reported experiencing disassociation symptoms. Johnson & Johnson calls the effects manageable and says they cropped up within an hour of the treatment, a period in which a person on the drug would likely be kept in the doctor’s office for monitoring. Some patients also experienced modest spikes in blood pressure within the same timeframe.

Nasal-spray dosing brings other issues. The Black Dog Institute in Australia and the University of New South Wales in Sydney, which teamed up to study a nasal-spray form of ketamine, published their findings last March in the Journal of Psychopharmacology. The researchers found that absorption rates were variable among patients. J&J says its own studies with esketamine contradict these findings.

But in the wake of the opioid crisis, perhaps the biggest worry is that loosening the reins too much on the use of ketamine and similar drugs could lead to a new abuse crisis. That’s why Wall Street analysts are particularly excited by Allergan’s rapid-acting antidepressant, rapastinel, which is about a year behind esketamine in testing. Researchers say it likely acts on the same target in the brain as ketamine, the NMDA receptor, but in a more subtle way that may avoid the disassociation side effects and abuse potential. Studies in lab animals show the drug doesn’t lead creatures to seek more of it, as they sometimes do with ketamine, says Allergan Vice President Armin Szegedi. Allergan’s medicine is an IV drug, but the company is developing an oral drug.

For its suicide study, Allergan is working hard to enroll veterans, one of the populations most affected by the recent spike in suicides, and has included several U.S. Department of Veterans Affairs medical centers as sites in the trial. More than 6,000 veterans died by suicide each year from 2008 to 2016, a rate that’s 50 percent higher than in the general population even after adjusting for demographics, according to VA data.

“How the brain mediates what makes us who we are is still a mystery, and maybe we will never fully understand it,” Szegedi says. “What really changed the landscape here is you had clinical data showing ‘This really does the trick.’ Once you find something in the darkness, you really have to figure out: Can you do something better, faster, safer?”

If you or someone you know is having suicidal thoughts, the National Suicide Prevention hotline is 1 (800) 273 8255.

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Depression Therapy With Party-Drug Roots Faces FDA Panel Review

Depression Therapy With Party-Drug Roots Faces FDA Panel Review

Depression Therapy With Party-Drug Roots Faces FDA Panel Review

NOVA Health Recovery : Call 703-844-0184 if you are interested in Ketamine Therapy for depression | Alexandria, Va 22306 | 22101 | We offer Esketamine and intranasal Ketamine therapy for PTSD, depression, anxiety and pain

Potential for abuse and strategies for containing any risks from an experimental depression treatment from Johnson & Johnson will be in focus at an Food and Drug Administration panel next week.

J&J’s nasal spray, esketamine, a close cousin of the party drug ketamine, will be considered by an FDA advisory panel on Feb. 12. While agency staff seemed satisfied that the likelihood of abuse is low, they raised questions about safety issues connected to a dreamlike sensation the medication can create in some users.

“Ketamine abuse is relatively uncommon in the general population,” agency staff said in a report ahead of next week’s meeting. Just 1.3 percent of people over age 12 abuse the drug, lower than abuse rates for other hallucinogens like ecstasy and LSD.

At the same time, reviewers worried that patients could get into accidents or otherwise be harmed if they leave a doctor’s office while still experiencing disassociation, a known side effect of ketamine — and a sought-after experience for casual users who have dubbed the spacey feeling the “K-hole.”

It takes roughly 90 minutes for disassociation symptoms from esketamine to resolve, according to the report. FDA staff also cited elevated blood pressure as a safety concern.

Esketamine is a key part of J&J’s pharmaceutical pipeline, as the company faces flagging sales this year weighed down by drug pricing scrutiny and looming generic competition. Its shares, which rose 2.3 percent this year through Thursday’s close, were were little changed in early trading on Friday.

In addition to weighing in on the drug’s safety and a proposed risk-evaluation and mitigation strategy, FDA staff will ask advisers to vote on whether esketamine effectively treated the depression of patients who weren’t helped by other therapies. They’ll also discuss whether additional studies are needed before or after the drug is potentially approved.

The staff report noted there were six deaths among patients taking the J&J drug, of which three were suicide in the esketamine depression program, but they didn’t see a clear link to the drug itself.

“Given the small number of cases, the severity of the patients’ underlying illness, and the lack of a consistent pattern among these cases, it is difficult to consider these deaths as drug related,” staff reviewers noted.

A decision on whether to allow the drug on the market is expected by March 4. Esketamine has the FDA’s breakthrough-therapy designation in treatment-resistant depression as well as for depressed people at risk of suicide. Results from a study in suicidal patients are expected this year. Allergan is also testing a fast-acting antidepressant, rapastinel, which is about a year behind esketamine in testing.