Ketamine Nasal Spray for Major Depression – The First Randomized Controlled Trial

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A Randomized Controlled Trial of Intranasal Ketamine in Major Depressive Disorder

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Psychiatrists from Mt. Sinai in New York this month have published the first randomized controlled trial of intranasal ketamine showing it is safe, well tolerated, and rapidly effective in treating symptoms of depression in persons with Major Depressive Disorder.

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This is a small study of 18 patients with treatment resistant depression showing a significant antidepressant effect occurred as early as 40 minutes in some. 44% responded after 24 hours compared to 6% placebo. Ketamine was significantly different from placebo at 40 minutes, 240 minutes, and 48 hours, but not separable from placebo at 72 hours or 7 days thought they were still better. And ketamine was significant at improving anxiety symptoms at 24 hours. There were no clinically significant changes in heart rate or blood pressure and all changes resolved in four hours. “No serious adverse events occurred.”

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“Intranasal ketamine was well tolerated with only very minimal increases in dissociation, psychosis-like symptoms or hemodynamic parameters.” They felt these very minimal behavioral side effects and insignificant changes in blood pressure and pulse were consistent with the lower blood levels of ketamine compared to the higher doses used in studies of IV ketamine. Bioavailability via intranasal route is reported to range from 25% to 50%.

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Their sample had an average of 4.1 ± 3.9 treatment failures, compared to 5.7 and 5.1 in previous studies – those required a minimum of 2 to 3 treatment failures to enroll. Other clinical characteristics did not differ including “duration of illness, length of current depressive episode, and history of ECT.” They allowed ongoing treatment of psychotropic medication.

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They chose a 50 mg dose based on a previous study and on the dose used in persons with a chronic pain disorder (Daniel Carr, et al 2004). It is a lower dose than the 0.5 mg/kg dosage commonly given intravenously. They point out one limitation of the study was the use of the single dose and a standardized protocol, which did not allow them to study optimal dosing. Future study is needed to address optimal dosing, relapse prevention and scheduling of treatment.

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The minimal side effects shown in their study correlates well with my experience. I find the effective dose of ketamine is idiosyncratic. That means it is unpredictable and specific only to that individual. Large males may need only the smallest dose, and tiny elderly females may require far higher doses. That may account for the higher response rate that I believe I am seeing, however, I have not tracked percentage of responders. I have not seen toxicity in years of prescribing either for intractable pain or treatment resistant depression. Importantly, in my opinion, relapse prevention must address not only different neurotransmitters but also neuroinflammation, pro-inflammatory cytokines.

 

 

 

 

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Oxytocin, Astrocytes, Modification of Amygdala Circuits and Pain – IASP Early Research Career Grant Report

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As a physician who prescribes Oxytocin [OT] and sees profound relief of many forms of intractable pain and/or relief of treatment refractory Major Depressive Disorder or Anxiety and Panic Disorder, this research on mechanisms is deeply meaningful and long awaited. Oxytocin is a hormone made in the brain, but also in the heart and other organs in women and men. It is rare to find work on glia and oxytocin.

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Today the International Association for Study of Pain announced the final report from their 2012 Early Research Career Grant:

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“Dr. Alexander Charlet of the Centre National de la Recherche Scientifique (CNRS) in Strasbourg, France, has submitted his final report for his project “Involvement of astrocytes in the endogenous oxytocin modification of amygdala microcircuits….”

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“Dr. Charlet’s project focuses on the functional consequences of endogenous OT release in amygdala microcircuits on nociception and pain. In addition, he aims to decipher the precise mechanism, cellular and molecular, by which OT exerts its action. Thus, the purposes of his project are to characterize in vivo and in vitro the effects of endogenous OT in the amygdala on pain-related symptoms….

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.….”In addition, he was surprised to discover that perceptions of his project’s importance grew once it was awarded and triggered future collaborations: a Marie Curie European Action Career Integration Grant and the French Initiative d’Excellence Attractivity.”

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“As a result, Dr. Charlet also received two major personal prizes: an award from Swiss Society for Biological Psychiatry in 2012 and award from the French Académie nationale de medicine with the prestigious Albert Sézary price in 2013. Finally, he has been recruited as a neurosciences permanent researcher by the CNRS and recently opened his independent lab.”

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me

to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Ketamine Inhaled – Bipolar Child NPR – Review of Ketamine for Depression

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NPR reported yesterday on the beneficial effects of ketamine for depression, this time reporting on a ketamine inhaler prescribed by Demitri Papolos, MD.

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Dr. Papolos is Associate Professor of Clinical Psychiatry at the Albert Einstein College of Medicine and Director of Research of the Juvenile Bipolar Research Foundation.

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He “is one of a handful of psychiatrists in the world who began to see and to speak out about the possible deleterious effects of antidepressants and stimulants in the population of children within the bipolar spectrum.”

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This NPR report described a syndrome Dr. Papolos has identified of Bipolar children & adolescents consumed by fear. They described a boy who had extreme attacks of rage for decades, and horrific violent nightmares.

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The boy had attempted suicide at age 5. He was hospitalized in a psychiatric unit at age 12 and strapped down in a padded room, terrified. He failed many medications for years, some made him worse, and he was literally never able to complete a meal at table with the family without flying off in a rage or someone leaving.

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in 2010, the boy tried Dr. “Papolos’ ketamine treatment. He says he’ll remember the day for the rest of his life. ‘I think we did two puffs, and I remember I sat up and I just started laughing,’ he says. Then his mother picks up the story: ‘You said you had an internal feeling of calm that you had never had before in your life. And when we came home that night, that was the first night that we ever all had dinner at the table without somebody leaving.’”

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This boy, George McCann, now at age 22 is finally able to begin a more normal life. He needs the medication only every third day. “Papolos has treated about 60 young people with ketamine so far and says all but two have had dramatic responses.”

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“The number of patients treated so far is small, and the approach is so new it hasn’t been tested by other researchers yet. Papolos says he’s hoping a study he published late last year will help persuade other researchers to try the drug on other children.”

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“In the meantime, George McCann continues to inhale a prescribed dose of ketamine every third day. The fear and anger that once dominated his life are gone, he says, adding that his mind is free now to work….”

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The relief with ketamine from the prison of mood disorders is deeply important. Severe mood disorders such as Major Depression and Bipolar Disorder can destroy the lives of patients and their loved ones. At worst, they can be lethal.

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A review of published cases of intravenous ketamine for depression asks : “Ketamine for depression: where do we go from here?

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I think the answer is we need to simplify the method of treatment using inhaled ketamine and begin to give their lives back to the patients we see. It is one of the safest medications I have ever prescribed. It does not cause weight gain or loss. It does not cause sexual dysfunction. And although it may increase sedation when used in combination with other sedating medications, at the low doses needed to treat mood disorders, I do not see ketamine interfere with other medication.

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Ketamine can relieve depression from one second to the next. And this young man needs the medication every third day. Is that too much to ask to gain a life?

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The material on this site is for informational purposes only, and is not a substitute for

medical advice, diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office or contact your local psychiatrist.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Ketamine Rapidly Relieves Depression by Restoring Brain Connections

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This research is one of the most dramatic findings in the field of depression and mood disorders. It was published in Science by researchers from Yale and the National Institute of Mental Health, discussed by PBS here.

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The speed with which ketamine can relieve major depression is deeply moving to witness. In my experience prescribing nasal ketamine it works almost 100% of the time. I have discussed ketamine and previous publications on it for Major Depression and PTSD. It is also effective for suicidal and bipolar depression patients.

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Ronald S. Duman, PhD, the lead scientist, reviews his group’s research in this 2011 video:

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Stress and depression leads to structural changes in the brain and these structural changes are reversible.

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Depression affects 17% of the population, almost one in five of the population. Only one third of patients are effectively treated by existing antidepressants, even after many weeks. Nerve growth factors, in particular BDNF, are decreased by stress, with a very significant loss in depressed patients. BDNF produces antidepressant behavior in rodent models of depression.

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BDNF is important for influencing the survival and function of neurons.

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There are certain neurogenic zones in the brain that produce new neurons. Stress decreases the number of new neurons. Chronic antidepressant use increases the numbers and proliferation of these new neurons. Antidepressant treatment increases neurogenesis and this is dependent upon BDNF, this neurotrophic factor.

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[His slide shows] Exercise, Prozac, ECT, antipsychotics, antidepressants increase neurogenesis.

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Not only are there more synapses made by ketamine, but they are a larger size which is indicative of ones that are more functionally connected. Antidepressants take many weeks. A single dose of ketamine rapidly reverses depressive behaviors and loss of connections and completely reverses the decrements that had occurred over several weeks.

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In suicidal patients given ketamine at Yale in the Emergency Room, within a matter of hours, the suicidality is completely reversed. These people are better for weeks after a single dose of ketamine treatment. [emphasis mine]

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Therapeutically ketamine is even more rapidly acting than ECT.

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Ketamine increases BDNF. But research shows its effects are blocked in mice that are deficient in BDNF. Riluzole also influences BDNF, but the side effect profile is so serious that I would not consider prescribing it without more data on safety.

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Safety concerns are often raised in publications regarding chronic ketamine use. Most of my patients have no side effects at all. It is one of the safest medications we have and only a small percentage experience transient side effects. The favorable side effect profile, simplicity and low cost is key. The results for nasal ketamine are not 100%, neither is IV ketamine, but I have patients who respond to nasal spray when they failed IV ketamine. More importantly, they can carry it in their pocket and use as needed.

 

My experience prescribing ketamine goes back almost to the year 2000 for persons with chronic pain who have used ketamine several times daily, and since Spring 2012 for Major Depression. Its effect for depression lasts longer than for chronic intractable pain where it is short lasting. In the past, I prescribed it orally, by mouth, but since late 2011 I have prescribed it in a nasal spray and that form works for depression.

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The neuroprotective action of ketamine has been published since at least 1988.

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Patients can use nasal ketamine as needed. Schedules vary, everyone is different. It is short acting, but it does not stop working.

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However, the use of other adjuvants, such as glial modulators, in treatment of depression is essential to understand, and is now work in progress. The role of inflammation and glia in the pathogenesis of depression has been well established since 2000, and discussed here.

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Does ketamine also restore brain connections in patients with chronic pain? Chronic pain and major depression both lead to brain atrophy and memory loss. Both cause the same imbalance in glial cytokines. Both may respond to glial modulators, e.g. low dose naltrexone among others that have worked in some patients.

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“The original link between ketamine and relief of depression was made at the Connecticut Mental Health Center in New Haven by John Krystal, chair of the department of psychiatry at Yale, and Dennis Charney, now dean of Mt. Sinai School of Medicine, who helped launch clinical trials of ketamine while at the National Institute of Mental Health,” reported by Yale  here.

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I hope to add new approaches to treatment of anxiety that has failed to respond to other interventions.

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The material on this site is for informational purposes only, and is not a substitute

 for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office or contact your local psychiatrist.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Depression, Ketamine, Naltrexone, Glia and Inflammation – A Case Report

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Current antidepressant therapies are only modestly effective, may have significant side effects and do not provide universal efficacy.

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The role of inflammation and immune systems in the pathogenesis of depression has become well-established since 2000. Immune system activity is mediated by pro-inflammatory cytokines that change behavior.

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This 2012 review is the first to summarize genetic variants of the inflammatory system involved in immune activation and Major Depressive Disorder, Major Recurrent Depression, Dysthymia, Childhood Onset Major Depression and Geriatric Depression: The role of immune genes in the association between depression and inflammation: A review of recent clinical studies. They reviewed 52 papers of which 27 are case-controlled studies. 

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Pro- and anti-inflammatory cytokines are produced by glial cells in the central nervous system (CNS). Glial cells make up 90% of the cells in the CNS; 10% are nerve cells, neurons. When glia are activated, they produce cytokines that lead to inflammation. Glia and inflammatory cytokines play a role in infection, stroke, trauma, chronic pain, Multiple Sclerosis, Alzheimer’s Disease, Parkinson’s Disease, ALS and Major Depression. The Nobel Prize was awarded in 2011 for discoveries of the innate immune system, in particular the mammalian Toll-like receptor 4 (TLR-4) which is the receptor for naltrexone. That discovery incidentally was made by Bruce Beutler at Scripps Research Institute.

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You can read more about glia and the inflammatory response posted January 2011: Pain and the Immune System – It’s Not Just About Neurons – Naltrexone. This is not specific to pain but also relates to some with major depression.

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Ketamine is a major anti-inflammatory and glial modulator. Naltrexone is a glial modulator that I have prescribed for chronic pain in low dose for almost four years in patients who are not taking opioids, and in ultra low microgram dose for more than eight years in patients who are on opioids for pain. Some of those case reports are posted on this site.

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Low dose naltrexone, LDN, may be effective for Autism, Multiple Sclerosis, and some autoimmune diseases. Jarred Younger at Stanford has shown fibromyalgia symptoms are improved by LDN; Jill Smith at Pennsylvania State University, Hershey, has shown remission in Crohn’s Disease with LDN; and Bruce Cree at UCSF has shown improved quality of life in a small study of Multiple Sclerosis that he is pursuing with larger multi-center studies.

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Case Report

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This week I saw a young man who traveled from Northern California for me to possibly treat major depression with nasal ketamine. Depression prevented him from working for the last two years. He scored 34 on the Hamilton Depression Rating Scale. Scores over 24 indicate severe depression. On June 4, 2012, we started his treatment using ketamine nasal spray. The daily dose was increased but has not yet reached an effective level. In my experience of prescribing ketamine for pain and depression in the last eleven years, the dose differs for everyone and is not related to age, gender or body weight.

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As conveyed by him to me, his progress thus far:

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ON JUNE 7, 2012, early morning, he used 40 mg of ketamine by nasal spray. He reported feeling dizzy, experiencing spinning sensation for two hours and then was his usual self, i.e. he felt bad the rest of the day as his usual self but vision was better. His strabismus (lazy eye) usually depends on better mood, but mood was unchanged.

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At 3:00 pm, he took naltrexone, a very low dose approximately 4 mg.

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ON JUNE 8th: approximately 12 hours later, he woke at 2 AM. He later told me that he was feeling “extremely sharp! I felt great! Clear in mind, quiet and calm. I didn’t realize how noisy my mind is till everything felt calm.” He returned back to sleep.

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He woke again at 6 AM feeling great! Not thinking negative thoughts, but no other change, i.e. did not like or love activities or people anymore than in recent years with his depression.

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At 1:15 PM, in the office his self-rated improvement of depression was 40% due to the low dose of naltrexone taken yesterday afternoon. He had no effect from ketamine as yet, and had not used any in more than 24 hours.

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My plan has been to trial low dose naltrexone for persons with treatment resistant depression. If it is effective, then ketamine is not needed. Ketamine is a short acting medication and may pose issues such as tolerance, whereas low dose naltrexone is simple, once daily, used with few side effects and has never caused tolerance in my clinical experience.

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It is very possible that with such rapid improvement overnight and continued treatment, his depression will continue to improve over coming weeks and months.

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The material on this site is for informational purposes only,

and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

.

Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office or contact your local psychiatrist.

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For My Home Page, click here: 

Welcome to my Weblog on Pain Management!

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Depression PTSD – Ketamine Rapid Relief

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  • PTSD has a more direct link to suicide than previously thought, a current Texas A&M University study concludes – references below.

  • A high lifetime risk of suicide occurs in women who have been sexually and physically abused as young girls.

  • More than 300,000 veterans have been diagnosed with PTSD or major depression – many not yet diagnosed.

  • Risk of suicide is the highest during the first month of standard antidepressant therapy, and a significant number of patients do not have adequate improvement even after months, resulting in harm to personal and professional lives.

  • Patients are at suicide risk upon discharge from psychiatric hospitals.

  • Significant predictors of both suicide attempts and preoccupation with suicide are guilt and anger and impulsive behaviors.

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  • Ketamine is the most important breakthrough in treatment of major depression with rapid and lasting effects.

  • Ketmine can help immediately, unlike all other antidepressants that may require weeks or months to work, if they help at all. See NPR report here - that appeared soon after I posted this (skip to their last section). It is FDA approved and legal. NPR again reports ketamine’s rapid relief of depression. A 28 year old man whose refractory depression began at age 15, after ketamine, says:

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    ‘I Wanted To Live Life’

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    Stephens himself has vivid memories of the day he got ketamine. It was a Monday morning and he woke up feeling really bad, he says. His mood was still dark when doctors put in an IV and delivered the drug.”Monday afternoon I felt like a completely different person,” he says. “I woke up Tuesday morning and I said, ‘Wow, there’s stuff I want to do today.’ And I woke up Wednesday morning and Thursday morning and I actually wanted to do things. I wanted to live life.”.
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    Since then, they treated him with Riluzole that is FDA approved for ALS and has one of the dirtiest side effect profiles I have ever seen in medicine with serious organ toxicity. Ketamine rarely causes mild transient side effects, usually none. It appears the concern is how ketamine is used on the street with potential for abuse. I do not see ketamine abuse in my patients, some of whom are on opioids for pain or Valium family medicines from their psychiatrist. All of those have a greater potential for abuse, also not occurring in my patients. Pain and/or depression can lead to suicide.
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    About 18 months ago, researchers at Yale found a possible explanation for ketamine’s effectiveness. It seems to affect the glutamate system in a way that causes brain cells to form new connections.
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    Researchers have long suspected that stress and depression weaken some connections among brain cells. Ketamine appears to reverse the process.

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    It would be of interest to see a case report of the bladder problems they mention. Is this in a single drug addict who used many unknown medications on the street? Several physicians have infused IV ketamine for persons with pain for many years, in far higher doses than I prescribe, with no report of any but transient minor symptoms.

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    Memory loss and brain atrophy occur with chronic depression, reported by the National Institute of Mental Health ~2001. The mechanism is described by Barsook referenced here.

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  • You do not need to be hospitalized.

  • A single low dose ketamine treatment, given nasally, may reduce core symptoms of PTSD and depression. It can save your life.

  • Relief of depression may occur in 2 minutes to 2 hours and may last 1 to 2 weeks.

  • National Institute of Mental Health published 100% relief in a group with depression refractory to all treatment that failed as long as 43 years.

  • You cannot anticipate when suicidal thoughts occur, but you can carry ketamine with you for instant relief.

  • Ketamine is not toxic, not expensive, side effects if any are transient – usually none. It is compounded by pharmacy.

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  • I can help. I’ve prescribed this medication for 11 years, spoken with some of the world’s foremost psychiatrists. Some of my patients with profound pain/depression travel to Germany for high dose ketamine coma treatment of RSD/CRPS and tolerate those doses. Ketamine is safe even in babies and children. Very few MD’s prescribe ketamine, and even fewer have much experience with it.

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  • I need to examine you in person.

  • I can meet with you at my office and it is essential that you meet with my colleagues, a psychologist and psychiatrist.

  • Time is of the essence because we may need to adjust the concentration of ketamine. We need to determine your comfort level with its use.

  •  This must be a team approach.

  •  Please ask your psychiatrist to call me with your diagnoses and speak with me in person.

  • If you live long distance, this team should include your local psychiatrist, or one nearby, who will prescribe ketamine for depression.

  • Alternately, I will need to see you in my office every few months to renew the medication.

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  • The medical literature on ketamine use is profoundly important. There are over 6,800 medical publications. Ketamine has potent healing powers. Karl Jansen, psychiatrist in London, believes that “ketamine has potent healing powers when used as an adjunct to psychotherapy.” There is nothing like it; however, treatment for serious depression still requires team support, not medication only.

  •  The World Health Organization reports that disability to due depression is second only to heart disease.

  • Suicide is a catastrophic medical emergency. I cannot stress this enough. Depression is treatable.

  • Your death is unnecessary. It would be a terrible loss to all who love you.

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    References
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    http://emedicine.medscape.com/article/2013085-clinical#aw2aab6b3b3
    Suicide Clinical Presentation

http://www.ptsd.va.gov/professional/pages/ptsd-suicide.asp The Relationship Between PTSD and Suicide  

PTSD alone out of six anxiety diagnoses was significantly associated with suicidal ideation or attempts. Anger and impulsivity have also been shown to predict suicide risk in those with PTSD.

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Articles, below, support use of ketamine for rapid relief of depression, even for resistant bipolar depression. The lead author of the first three studies is Carlos Zarate, M.D., Chief of the Mood and Anxiety Disorders Research Unit of the National Institute of Mental Health, NIMH:

http://www.ncbi.nlm.nih.gov/pubmed/20673547   Rapid resolution of suicidal ideation after a single infusion of an N-methyl-D-aspartate antagonist in patients with treatment-resistant major depressive disorder

100% response in persons with refractory depression: 29% went into remission, another 71% were responders.

http://archpsyc.ama-assn.org/cgi/content/full/67/8/793  A Randomized Add-on Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Bipolar Depression It even works for resistant bipolar depression

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2726824/figure/F1/  Ketamine and the next generation of antidepressants with a rapid onset of action

Potential targets for ketamine and similar agents induce rapid and sustained antidepressant effects. A diagram scientists and physicians will find useful for mechanisms. “Notably, ketamine’s rapid antidepressant effects have been shown to be modulated by AMPA relative to NMDA throughput. Excessive glutamate also stimulates the extrasynaptic NMDA receptors, which antagonizes the activation of neurotrophic cascades. The potential sustained (sub-acute) antidepressant effects of ketamine are hypothesized to be mediated by increases in CREB and BDNF expression, as well as the anti-apoptotic protein Bcl-2.”

https://www.sciencemag.org/content/329/5994/959.abstract mTOR-Dependent Synapse Formation Underlies the Rapid Antidepressant Effects of NMDA Antagonists

“The rapid antidepressant response after ketamine administration in treatment-resistant depressed patients suggests a possible new approach for treating mood disorders compared to the weeks or months required for standard medications….Our results demonstrate that these effects of ketamine are opposite to the synaptic deficits that result from exposure to stress and could contribute to the fast antidepressant actions of ketamine.”

http://psychiatry.jwatch.org/cgi/content/full/2010/1008/5 Ketamine’s quick antidepressant actions

“The resulting protein synthesis and neuronal alterations in the medial prefrontal cortex are the opposite of those produced by chronic stress….”

 

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The material on this site is for informational purposes only, and is not a substitute

 for medical advice, diagnosis or treatment provided by a qualified health care provider..

~

Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office or contact your local psychiatrist.

~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Carry On —> Inspiration

keep-calm-and-carry-on

This is a Cinderella story that will melt the most cynical heart.

Susan Boyle, the British singer, is an instant sensation!

Over 85.2 million viewers have seen her on YouTube in just one week – a record -

to watch her sing “I Dreamed A Dream from Les Miserables.

Born with brain damage, she was taunted all her life because she is slow.

Asked how she had the confidence to sing in front of a large audience, she says:

” I just had the ability to keep going.  You have to keep going.”

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…..a beautiful, inspiring video

of Nick Vujicic, born with no limbs, speaks to students

whose tears run down their cheeks, whose love pours out to him.

Nick has found the purpose of his life and has become strong

through the agony of learning how to overcome what had defeated him from birth.

The miracle we are looking for is inside each of us.·



For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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