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mr peabody

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Why you need to be careful about the Ketamine clinic you choose

by Troy Farah | DoubleBlind | 15 Oct 2019

Ketamine could pave the way for legal psychedelics—if careless clinics don’t get in the way.

When Dr. Erica Zelfand began her family medical practice, she didn’t have to write many prescriptions for antidepressant and anxiolytic drugs before she realized she needed to find something else. The long list of serious side effects from these drugs, coupled with the length of time it takes for some antidepressants to kick in, means they just don’t work all that well. And when patients fail to respond to two or more drugs—which happens with 7 to 35 percent of patients who suffer from depression—their condition is considered “treatment-resistant.”

Faced with this growing issue, Zelfand shifted her practice to focus on diet, lifestyle, and mindfulness—which got her paying more attention to psychedelic science.

Before I knew it, I found myself volunteering with MAPS, reading books on entheogenic healing, and attending conferences,” Zelfand says in an email. “Integrative mental health is now a focal point of my work, and I find it immensely rewarding.”

Zelfand says the global mental health crisis—which has led to a slight drop in average life expectancy over the past three years in the U.S. alone—is forcing healthcare practitioners to grapple with conditions outside their expertise. “The urgent need for a therapy to help patients survive and thrive through depression is perhaps why providers who don’t typically treat mental health conditions or who don’t particularly resonate with the field of entheogenic healing are suddenly interested in ketamine,” Zelfand says.

Depending on whom you ask, the effects and use of ketamine can be described completely differently. Most anesthesiologists simply view it as a potent painkiller, with fewer side effects than opioids—it is, after all, the most widely used anesthetic on the planet, according to the World Health Organization (WHO).

For many cutting-edge therapists, however, ketamine is a wonder drug that can rapidly relieve suicidal thoughts, PTSD and symptoms of depression. Suicide claims a life every 40 seconds, according to the WHO, making it the 10th leading cause of death in the United States and the number two killer among people between ages 10 and 34. While some antidepressants can take weeks to kick in, ketamine can alleviate symptoms in just a few hours, although this relief isn’t always permanent and not every patient responds to the drug.

With its growing public acceptance and proven efficacy for patients, ketamine is perceived to be the first legal step toward a Western society that uses psychedelics-at-large to heal the mind. With ketamine leading the way as psychedelics emerge from the underground, indeed, some ketamine clinics are already gearing up to offer MDMA and psilocybin in a similar fashion when these substances can also be legally prescribed. (MDMA therapy is slated to be legal by 2021 and psilocybin for depression isn’t far behind.)

But some experts are concerned about not only the hype over ketamine’s purported capacities to heal, but also the less-than-scrupulous health centers touting ketamine without more oversight. According to an investigation by Megan Thielking of STAT, these clinics may not be thoroughly pre-screening patients’ physical and mental status or may lack mental health experts on staff, which can lead to mismanagement of delicate mental states. It’s not enough to just be given ketamine—some patients require counseling or integration back into society as a way of making sense of their experience.

Something like 90 percent of the long-term benefit of psychedelics is in the sober integration in the weeks and months after,” says Dr. Will Siu, a MAPS-trained, NYC-based psychiatrist who prescribes ketamine lozenges to some of his patients. “There’s probably a number [of patients] who feel a lot better, but then it fades with time because they don’t have integration.”

Siu and Zelfand say many ketamine clinics are run by anesthesiologists or primary care doctors offering the drug as a side business. And it can be lucrative, costing hundreds of dollars, though some insurance companies are slowly starting to cover it.

Ketamine is a big moneymaker, with providers charging anywhere from $150 to $700 cash per treatment,” Zelfand says. “A treatment often consists of very little face-to-face time, as patients are typically left alone in a room while an automated pump delivers the intravenous infusion. When you consider the common prescription of a loading program of six infusions within a two-week period, followed by a maintenance plan of an infusion every four to six weeks thereafter, indefinitely, that’s a lot of money—and a lot of incentive for administering ketamine.”

Zelfand isn’t accusing any providers of being in it solely for the cash, but the profits of these services can’t be ignored, either. (Esketamine, Johnson & Johnson’s blend of ketamine recently approved by the FDA, is generally even more expensive than these generic blends.) Zelfand is also concerned that some clinics are prescribing ketamine with sedatives like midazolam, a benzodiazepine, to dampen the hallucinogenic “side effects.”

Not only have benzos been shown to make ketamine less effective, but those “side effects” that help patients step outside their egos are central to the treatment, argue Zelfand and other experts like Steve Mandel of Ketamine Clinics of Los Angeles. “A mystical journey is not a mere nuisance side effect of a treatment, but rather a significant component of the treatment itself,” says Zelfand.

I sometimes use the analogy of an impressionist painting: what looks like a chaotic mess of color upon color, in fact, reveals itself to be a beautiful landscape of water lilies at dusk when viewed from across the room,” she adds. “Ketamine allows a patient to step away from the ‘canvas’ of his [or] her life and consider it from a more distant, detached perspective—and this can lead to profound psycho-spiritual breakthroughs.”

If ketamine really is a bridge to mainstreaming psychedelic culture, some of these clinics need better management, or they could risk giving the whole movement a black eye, says Jamon R. Rahn, director of Mind Medicine Inc., a startup dedicated to using psychedelics to treat addiction. To address this, Rahn, a Silicon Valley investor who formerly helped Uber expand in Singapore, is investing into a network of ketamine providers that will adhere to standards of care, through a potential accreditation process.

I went to some of these ketamine treatment centers around the United States and was actually horrified,” Rahn tells DoubleBlind. “Ketamine is really creating a new treatment paradigm, but some are doing it, I think, in the wrong manner and I think it’s the single biggest existential threat to the psychedelics community.”

While there are clinics that do provide good quality care, Rahn says he’s worried the bad ones will lead to a repeat of the 1960s, when hype surrounding psychedelics was met with public backlash and strict bans that set research back decades. “While there is a psychedelic renaissance underway, without proper controls and regulations this could turn into another apocalypse for these medicines,” he says. "The solution is to start raising awareness about what a proper ketamine treatment should look like and to implement standards of care."

What we do is educate therapists and educate the public,” says Siu. “If we actually have good practitioners out there, and patients know that there is such a thing as different sets and settings, these other clinics won’t last.”

 
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Society announces Standards of Practice for the therapeutic use of Ketamine*

CISION News Wire

Ketamine, originally developed as an anesthetic, has emerged as the biggest breakthrough in 50 years for the treatment of depression and suicidality. Despite a growing body of research surrounding its use, guidelines establishing recommendations for best practices have been limited. The American Society of Ketamine Physicians, Psychotherapists and Practitioners (ASKP3) is a group of professionals dedicated to the safe and clinical use of ketamine for mental health disorders and pain conditions that was developed in 2016 and has over 400 members of various specialties. ASKP3 recognizes the lack of formal guidance and seeks to protect and foster the use of subanesthetic ketamine by providing recommendations for standards of practice.

Patrick Sullivan, DO, the lead author of the standards and current ASKP3 board member, further elaborates on the need for standards. "As the excitement grows about the rapid and powerful effects that ketamine has against depression and suicidality, so does some concern about the number of clinics opening to treat it. More specifically, the qualifications and experience of the clinicians providing the care. The ASKP3 board of directors is made up of many of the field's most experienced providers and we felt it was essential to set the standard for the safe and effective use of this life-saving medication."

At this time, many different specialties provide treatment with subanesthetic ketamine. One of ASKP3's goals is to create and encourage a space where safe practices and standards are discussed, implemented, and updated on a continuing basis that grows with the needs of this rapidly expanding field. Sandhya Prashad, MD, ASKP3 President and founding board member, details, "There is a lot of variability between clinics administering ketamine and recommendations are essential to protect this valuable treatment. The number of clinics continues to expand rapidly and a clear standard is absolutely necessary." ASKP3 recognizes that the development of best practices will be a dynamic process that continues to evolve as the knowledge base expands and further data becomes available.

*From the article here :
 
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How Ketamine is helping people with Treatment Resistant Depression

by Amelia Walsh & Dr. Benjamin Malcolm, PharmD, MPH, BCPP | PSYCHABLE |

In recent years, ketamine and the innovation of its use for treating different forms of depression has become increasingly more interesting as it is evident that it can provide rapid relief to persons with treatment-resistant depression.

Depression is the most common cause of disability, but many people experience side effects or do not find adequate relief from conventional treatments. It is estimated that 10-30% are resistant to beneficial effects of traditional antidepressants.

Here are answers to some of the most common questions about the possibility of adding ketamine to a course of treatment for depression.

What is ketamine?

Ketamine was initially used during surgery as an anesthetic and as an alternative to pain medicines like morphine, but it has since been researched and approved for use to help people with treatment-resistant depression.

Experts in the field of mental health are optimistic about the treatment. It can offer significant benefits to those who have been unsuccessfully treated with other medications. It produces a dissociative and psychedelic effect that users find insightful and is linked to clinical improvement.

Ketamine’s landmark studies for depression were done using intravenous infusions, however a nasal spray was approved for use by the Food and Drug Administration (FDA).

It is now offered in therapeutic settings via a variety of administration routes, including infusion, intramuscular injection, intranasally, by mouth, and even sublingually (under the tongue).

When used therapeutically, it is given a few times a week for a few weeks as an initial round of treatment, followed by a period of observation for response. Some may return for treatments on a regular schedule or discontinue use of ketamine after a few rounds of treatment.

Use of ketamine in a clinical setting is evolving, although it appears that ketamine-assisted psychotherapy (KAP) offers significant benefits in treatment response and harm reduction relative to ketamine use in recreational or even supervised settings that do not give supportive psychotherapy.

While it is still unclear as to the exact reasons ketamine works for depression, what is known is that it operates on different neurotransmitters and receptors. Whereas most antidepressants work on neurotransmitters like serotonin, ketamine primarily modulates a neurotransmitter called glutamate, which is involved in brain plasticity and are partially responsible for mood regulation.

Does ketamine really work for depression?

Ketamine is an exciting development because it acts rapidly and tends to produce robust beneficial effects when it does work. Most antidepressants can take weeks to achieve full results and their overall effects are often modest. The opportunity to quickly achieve significant improvement is a welcome innovation.

Ketamine may help repair connections in the brain by inducing a state of neuron plasticity, allowing the potential for significant shifts in negative mood states as well as longer-term change.

Ketamine is not a lifetime commitment when it works well; it is a series of treatments that occur over a relatively short period of time (depending on the case), and can offer lasting symptom relief if successful.

Ketamine for bipolar depression

Bipolar depression is one of the most likely psychiatric conditions to cause suicidal ideation and be resistant to treatment. Ketamine has been studied with mood stabilizers such as lithium or valproic acid and is shown to be effective for bipolar depression. It has some promising studies showing rapid anti-suicidal effects. Use for serious mood disorders such as those with suicidality should be attempted only under the supervision of professionals with close monitoring.

Ketamine for severe and treatment-resistant depression

Typical antidepressants work on what is called the monoamine system, targeting neurotransmitters like dopamine, norepinephrine, and serotonin. They are typically a successful form of treatment for depression, but those suffering from major depressive disorder (MDD) can sometimes be resistant to treatment and be candidates for additional methods of therapy.

Ketamine for major and clinical cases of depression that are resistant to treatment can be effective when other methods alone are not. It can also be used safely and effectively in conjunction with traditional antidepressants, in fact this is how the FDA approved ketamine nasal inhaler, esketamine (Spravato) is intended to be used.

In cases of severe depression, ketamine has offered rapid relief of symptoms in controlled medical studies with transient or short-lived side effects around the time of ketamine administration.

Ketamine is not currently considered the first option for treatment of depression, but it is becoming more and more common for health practitioners to consider it when the most commonly prescribed pharmaceuticals do not provide adequate relief.

Ketamine works quickly, sometimes within hours of receiving treatment. So it could be a game changer for those with severe depression for whom the condition poses a danger.

When major depression is resistant to treatment, it typically means that the common drugs prescribed have not been effective. It can also take weeks to see improvements, if the medicine works at all for the patient. In the meantime, many people are at risk for suicidal ideation and susceptible to the damaging effects of treatment-resistant depression.

Ketamine can improve symptoms within just a few hours of treatment, working on different receptors in the brain and possibly offering long-term relief with multiple doses over time.

How to take ketamine for depression

There are a few different ways you can take ketamine for depression. The right method is different for everyone, and the best way to find out is to speak with a knowledgeable practitioner. Here are the options:

Drip or intravenous infusion

An IV drip (intravenous ketamine treatment is also called an infusion) allows the medicine to bypass the digestive system and enters directly into the bloodstream. It is among the most common ways to receive ketamine treatments for depression and one of the methods with the most data supporting it.

Studies have shown relief within 4 hours and possible remission of depressive symptoms in as little as a week after infusion treatments for certain patients. Infusions may be given in a series of treatments, for example a person may receive a ketamine infusion six times in two to three weeks as an initial round of therapy.

The number of treatments and frequency of administration depends on the type of diagnosis. Typically, symptom relief occurs within one to three treatments, however sustained benefits are more likely with additional treatments (particularly in the case of treatment-resistant depression).

Intravenous infusions are typically administered over 40 minutes, although the user may need to stay at the treatment center to be monitored and receive supportive psychotherapy after administration.

Injections or intramuscular shots

While less well studied, intramuscular (IM) injections of ketamine to treat depression are being studied and could offer the same effective, rapid relief as IV treatment. There’s still more to learn, but the preliminary results appear promising. One major advantage of IM injections compared to IV infusions is the fact that there is no insertion of an IV line or need for an infusion pump, making it simpler for practitioners and patients.

Nasal inhaler

The FDA-approved version of ketamine for treatment-resistant depression is a nasal spray of one type of ketamine or esketamine (Spravato). It’s a nasal spray or inhaler administered by the patient under the supervision of a practitioner.

Two schedules exist for dosage and frequency, one for treatment-resistant depression (TRD) and another for a shorter term of use in addressing major depression with acute suicidal ideation (MDSI) prior to the onset of a standard antidepressant medication.

Treatment of TRD starts with a 56 mg dose as frequency and additional doses are adjusted over the course of 9 weeks, or longer if deemed necessary.

Treatment for MDSI is administered for 4 weeks, with an 84 mg dose taken twice weekly.

A patient takes the medicine themselves, and is then monitored by a practitioner or their trained staff for up to several hours to ensure safety.

Because esketamine can cause disorientation, dizziness, or other side effects during and immediately following treatment, it is important to comply with safety policies during and after treatment, as well as avoid the operation of a vehicle for the rest of the day after use.

Ketamine and psychotherapy

One study about ketamine assisted psychotherapy discusses the administration of small doses of ketamine during a talk therapy session and the benefit of that session to someone suffering from treatment-resistant depression.

Because ketamine can allow a person to be less preoccupied by inhibitions and feel more open to a discussion, these sessions may offer a new way to approach depression therapy and more effectively address factors like previous exposure to trauma. In addition, the authors document beneficial effects of ketamine in larger doses with supportive psychotherapy for many other conditions including PTSD, ADHD, and generalized anxiety.

Psychotherapy is a helpful treatment for depression, whether ketamine is used simultaneously to facilitate a therapy session or the treatments occur at different times. The potential benefits of ketamine can generally promote a greater sense of well-being, increasing the possibility of full participation in the therapeutic process or greater engagement with therapy on behalf of the patient.

Is ketamine legal?

Ketamine is a legally available medicine for anesthesia, depression, and is commonly used for other purposes. It is an ‘essential medicine’ due to its low cost and high utility according to the World Health Organization (WHO). It is the only legal psychedelic therapy available for treating depression in the United States for most people at this time, but that may change.

Ketamine is not legal for recreational purposes, and can be dangerous if used improperly.

Is ketamine treatment approved by the FDA?

The FDA (U.S. Food and Drug Administration) has approved esketamine (Spravato) for the treatment of depression in conjunction with traditional antidepressants.

Use of ketamine outside the FDA-labeled indication is termed ‘off-label’ use.This simply means the FDA has not approved of it for that purpose, although could be quite reasonable to use for that purpose due to supporting studies. Ketamine practitioners using higher doses or routes of administration different than those in formal clinical trials are engaging in ‘off-label’ use. In some cases this could be helpful and offer additional benefit, while in others it may be too experimental and carry increased risks.

Is ketamine for depression safe?

It is important to know that ketamine taken in high doses is used for anesthesia purposes, but does not have the same effect with subanesthetic doses used in depression.

That being said, side effects do occur with low doses administered to treat depression. Study participants have reported symptoms like feeling odd, the sensation of floating, sedation, dissociation, and impaired cognitive abilities. Physical side effects can include increased blood pressures and heart rates, dizziness, vomiting, and headaches.

The long-term effects of treatment with ketamine are not currently known. Further studies are required to discover any risk of lasting impacts that could exist.

The infrequent doses are administered under the supervision of a professional in a clinical setting, followed by health monitoring and observation for a period of time after treatment. This helps ensure safety after treatment, as the common side effects can be dangerous if a person is not supervised until they subside.

Ketamine is not taken daily, and currently not at home without supervision or guidance of a trained practitioner. Working with a practitioner and receiving the medicine with medical supervision is the only way to be confident that treatment will be as safe as possible.

It is important to note that ketamine is commonly misused as a street drug, and can have addictive properties if taken without the guidance and supervision of a practitioner. When used improperly, it has the potential to cause psychological and physical harm such as neurocognitive problems or difficulty functioning normally and lower urinary tract symptoms like a bloody bladder, pain, or inflammation.

Is ketamine for depression addictive?

Ketamine is a schedule III controlled substance in the US and does carry risk of habituation, tolerance, and addiction in recreational or unsupervised settings. Because of the lower dosage and intermittent use pattern of supervised treatments, it’s less likely that you’ll become addicted to ketamine. Currently, most ketamine treatments occur in a clinical setting and not at home.

Always work with a practitioner who can help ensure the correct dose and frequency of ketamine and esketamine to avoid the risk of addiction or dependency. Individual use not regulated by a professional increases the likelihood of abuse, in addition to the dangers of possible side effects in a non-clinical setting.

Is ketamine for depression covered by insurance?

Because ketamine is not considered the first line of defense against depression, some insurance companies will not cover it.

However, some plans will cover ketamine for depression if certain criteria are met, such as trying at least two or more medications that haven’t helped at all on their own. In this case, insurance companies will likely review a case and may require completion of prior authorization procedures.

It is always best to speak with an insurance company for information about what is covered and which steps can be taken to have treatments approved if a plan allows coverage for ketamine treatments.

Where can I get ketamine for depression?

It is not recommended that individuals acquire or use ketamine themselves, as there are serious concerns about dosage and safety that require oversight by a professional. Additionally, attempts at self-medication increase the likelihood of dependency, addiction, and health risks. Ketamine, if deemed appropriate, is only one part of a treatment regimen that may require conjunctive prescription antidepressants, behavioral therapy, or other interventions and lifestyle changes for best results.

As ketamine research continues to provide a greater understanding of its effect on depression, it is becoming more widely available for therapeutic use from mental health professionals. To ensure the quality of a medicine and safe use, connect with an experienced practitioner. They can provide ketamine treatment that is right for a person’s individual needs.

Access a list of practitioners by checking out the Psychable’s directory today.

 
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Making Ketamine Therapy Affordable*

by Matthew Dunehooon | Psychedelic Spotlight | 22 Feb 2022​

At the beginning of the month, Los Angeles-based nutraceuticals company Irwin Naturals announced its ketamine clinic rollup strategy, starting with Midwest Ketafusion, a ketamine treatment clinic in Iowa City, Iowa. Midwest Ketafusion will be rebranded as Irwin Naturals Emergence, and the company’s vision is to become the leading chain of ketamine treatment clinics in the world.

What wasn’t immediately clear from reading the press release is the real revelation and rationale in the work Irwin is doing to drive down costs, providing wider access to individuals needing the radically effective treatment the most.

Since 1994, Irwin Naturals has been in the plant medicine game. The goal was always to provide the highest quality nutritional supplement product for the mitigation and prevention of a wide array of ailments, at a price point people could afford. From years spent focused on the wellness space, Klee Irwin, founder and CEO of Irwin Naturals can outline three “uber” disease categories: mental health, cardiovascular diseases, and cancers — with hundreds of other diseases living under the umbrella of those three major categories.

It’s Irwin’s belief that while instances of occurrence of disease within the two former categories have grown at a linear rate, in recent years we’ve entered into a “doubling algorithm” for mental and behavioral diseases. It’s this disconcerting phenomenon that has captured the attention of policy makers of all political orientations, and made celebrities and other high-profile influencers step to the forefront of the effort to address and destigmatize mental and behavioral health awareness, broadening the public dialogue. This dialogue increasingly encompasses discussion of psychedelics as contenders for not only treatment of, but a possible cure for diseases and disorders that transcend all demographic distinctions and are insidiously destructive to the wellness of civil society.

At present, the only psychedelic medicine that has been approved for off-label use by the FDA is ketamine. And there continues to amass a substantial body of evidence for its efficacy that far surpasses, in dramatically shorter time windows, the success rates of previously utilized pharmaceuticals for the treatment of depression, anxiety disorders, PTSD and more.

But as the rift between classes in the U.S. widens, the diseases that can affect the poorest among us continue to be some of the hardest, most cost-prohibitive to treat.

“Ketamine has been used for decades, as the go-to anesthetic in surgeries. It’s very, very well understood in terms of its side effects, how to mitigate side effects and risk. It’s a rock solid, familiar drug. And it’s perfectly legal for doctors to prescribe it off label for any mental health condition that they want,” Irwin tells Psychedelic Spotlight. “But here’s the rub. Insurance isn’t paying for those off-label uses.”

“And the problem from an ethical standpoint is that when it comes to cancer, it doesn’t really track to sociopolitical status or income,”
he continues. “It doesn’t track to how much money you make or how much education you’ve had. When it comes to mental diseases, some of them track to income.”

For example, Irwin points to the increased likelihood of low-income women being sexually assaulted, or low-income young men joining the military, with both experiences potentially yielding severe PTSD. “The point is, those among us suffering the most from the opioid epidemic, which is a self treatment of these mental health problems, [are] those suffering from trauma,” says Irwin.

By acquiring and bringing the day-to-day operational expenses of a chain of ketamine clinics under the Irwin Emergence umbrella, the cost of business can be more effectively scaled and consolidated by an already largely profitable entity. By doing so, the standard for treatment expenses can be radically disrupted. Those among us who might need a treatment regimen of six infusion sessions but who could never afford a $3,000.00 cash cost, will finally have a shot at getting the care they need.

Irwin alluded to the success of the Jenny Craig model, in providing accessible weight management counseling options for the mass market by driving down costs through economies of scale and best practices.

“I have a brand that’s known by eight out of ten American households. I can lend it to the cause,” Irwin says. “I also have an intention. I want not to be greedy. I want to make my money by making a small profit on the masses rather than a big profit on an elite, smaller group of customers. That’s just good business. I don’t have to be altruistic to have that common sense. If you’re going to be a mass market leader, you must be priced for the masses. And it is business sense for me, but it’s honestly driven by a big bleeding heart, a sense of social responsibility.”

He adds, “You know, when there’s a zombie apocalypse, those of us who have the ability to do something about it should step up to the plate and try to help, even if it doesn’t make us trillionaires.”

*From the article here :
 

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Ketamine could treat Parkinson’s, study*

by James Hallifax | Psychedelic Spotlight | 23 March 2022

PharmaTher had the goal of evaluating “the safety, tolerability and efficacy of low-dose ketamine infusion for the treatment of LID in patients with Parkinson’s Disease.” On all three counts, it appears to have exceeded expectations.
It seems that ketamine is having a moment. Originally discovered in 1962, the dissociative psychedelic has been used mainly as an anesthetic (pain killer) in the medical establishment for decades.

In recent years, however, its medical uses have ballooned, as evidence emerges that its potential benefits range from treating depression, to addiction, to ALS. Across North America, ketamine clinics have been sprouting like dandelions in spring, legally treating mental health conditions such as depression.

Now, evidence is growing that the psychedelic can also treat a debilitating aspect of Parkinson’s Disease.

Today, PharmaTher announced topline results of their Phase 2 study using ketamine to treat Levodopa-Induced Dyskinesia (“LID”) in patients with Parkinson’s Disease.

Before getting to the results, let’s take a moment to understand LID. Basically, when a patient shows symptoms of Parkinson’s — a brain disorder that can cause uncontrollable shaking, and difficulty with walking, balance, and coordination — the most common treatment is a drug called Levodopa. And while this drug is effective in treating the symptoms, over time the side effects of Levodopa treatment start to mirror that of Parkinson’s itself. After five years of treatment, roughly half of patients will experience abnormal and uncontrollable bodily movements. Within 10 years, it will affect nearly everyone. This is LID, and it is currently basically untreatable.

Enter ketamine.

In the current study, PharmaTher had the goal of evaluating “the safety, tolerability and efficacy of low-dose ketamine infusion for the treatment of LID in patients with Parkinson’s Disease.” On all three counts, it appears to have exceeded expectations.

Starting with efficacy, PharmaTher says the study “demonstrated that 100% of patients treated with ketamine demonstrated a reduction in dyskinesias (LID).” Now, while this is certainly impressive, it must be noted that PharmaTher’s early topline data did not specify by how much, on average, patients saw the dyskinesias symptoms decrease; only that they did. Full data is expected to be released in June.

On safety and tolerability, “the study demonstrated that ketamine was well tolerated with no serious adverse events reported. All adverse events were mild or moderate and reflected the expected side-effects of ketamine administration.”

So, despite not having the full data available, we can say that the results are very positive indeed. I am looking forward to writing about the full data in June.

Though the public doesn’t yet have the full data, PharmaTher is confident that it is positive enough to greenlight a Phase 3 trial this year. This trial will use PharmaTher’s proprietary ketamine intravenous product, KETARX™. As a reminder, a drug must pass through two Phase 3 trials before being approved to treat a condition. Though, as ketamine itself is already legal, doctors can prescribe it “off-label,” meaning that doctors, lacking other options, could likely already try this therapy.

Parkinson’s is a tragically large problem. More than 1 million people in the United States, and more than 7 million people world-wide, suffer from the disease. And while the drug Levodopa does certainly help them, the long-term consequences of taking it leave much to be desired. Hopefully, future studies continue to show ketamine’s effectiveness, and these 7 million plus individuals can get the help they deserve.

From a business perspective, the treatment market for LID is estimated to be more than $3 billion annually in the US alone. If PharmaTher can tap into this market, the company, currently with a tiny market cap of $15 million CAD, could see big days ahead. However, it must be noted that many companies produce and deliver ketamine, so even if PharmaTher proves its effectiveness in treating LID, it would face stiff competition.

Stepping back, this trial illustrates a BIG TREND in psychedelic medicines that Psychedelic Spotlight will be watching closely over the coming years: the transition of psychedelic medicines from treating solely mental health conditions, to treating physical health conditions. While we certainly do have a mental health crisis, battling traditional health issues is also important. Recent studies have shown that psychedelics may be useful in treating conditions as far ranging as eating disorders, to chronic pain, to strokes, and Alzheimers.

At the end of the day, one of our goals as a species should be to lessen the pain and despair found on our planet. With each passing month, as more clinical data is released, it appears that psychedelic medicines such as ketamine, psilocybin, MDMA and LSD can help us achieve this lofty goal. We must put aside the stigmas of the past, and begin to view these molecules as medicines, rather than dangerous drugs that must be illegal.

*From the article here :
 
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At-home Ketamine Therapy — are you ready?

Will this at home “tripping kit” change mental health forever?

There is a shadow cast over Dylan Beynon’s family.

“I grew up with a family just annihilated by mental illness,” Beynon says. There is a history of schizophrenia; his mother was an addict who spent 15 years homeless before dying of a fentanyl overdose. The pain is immediate and intimate.

“And through those experiences, I came to really prioritize my own mental health and wellbeing, because I was so afraid of falling into the path she fell into,” Beynon says.

It appeared to be working. Beynon achieved academically, had friends, had a partner, and yet … he was deeply unhappy.

“I did not have a positive relationship with other people and the world around me,” Beynon says.

While searching for something to help, he found an option that some clinical data showed outperformed traditional treatments: ketamine therapy.

Beynon is now the founder and CEO of Mindbloom, a startup which seeks to make ketamine therapy more accessible by providing physician prescribed drugs, kits including masks and journals, and guides, making the treatment available in the home, rather than at clinics.
It’s another step toward expanded clinical use for a drug that is as crucial on battlefields as it is in vet offices.

A brief history of Ketamine

“Ketamine is, like, utterly fascinating for a lot of reasons,” Beynon says. “But its history is one of the most interesting parts about it.”

Ketamine was first synthesized in 1962. Developed as an anesthetic — for both humans and, more famously, animals — the drug, despite its clubby reputation, is useful and important in medicine.

Anesthesia, as critical as it can be, carries risks that can be pretty significant — that’s why there’s a whole medical speciality dedicated to the planning and administering of them. In this powerful class of drugs, which can cause permanent damage or death when used incorrectly, ketamine stands out for its relatively safe profile.

The drug does not suppress breathing and blood pressure as much as other anesthetics, and has a wider margin for error in dosing. This makes ketamine ideal for use in chaotic situations like war zones and for children, earning it a place on the World Health Organization’s essential medicines list, drugs that the organization considers the bare essentials for any health system.

But ketamine also has a bizarre quirk: when it is taken at lower doses, below the anesthetic threshold, it becomes a powerful psychedelic, giving it a second life on drug world dance floors.

It can cause a feeling of detachment from the self and reality, in trips generally lasting for 30-60 minutes.
The short duration and low dosage makes it a popular alternative to similar drugs like PCP.

In 2000, Yale’s John Krystal discovered another surprising ketamine ability: it was a potent and fast-acting antidepressant. It was so potent and fast-acting, in fact, that it rightly took years for researchers to accept what the clinical data was showing, Krystal previously told Freethink.

In the two decades since, ketamine therapy has emerged as a promising option for treatment-resistant depression, joining other psychedelics like psilocybin (one of the key compounds in magic mushrooms) and MDMA-assisted therapy.

A new class of antidepressant
'
Traditional antidepressants can and do work in the treatment of depression. The problem is that they do not work well enough for many patients, and sometimes not at all for others. Patients who begin a new antidepressant may have a 10-20% chance of response, Krystal previously told Freethink.

In comparison, ketamine produces response rates in 50-80% of patients, and it does so far faster, within days. Traditional antidepressants need to be taken daily, and often for weeks for their effects to begin.

When it comes to why ketamine is such an effective depression treatment, well… we don’t really know. In fact, there’s a lot of drugs whose exact mechanisms of action are unknown, but researchers are currently trying to tease out what is going on in that complex neuropharmacology. If the key to the speed of ketamine therapy is discovered, we may be able to use that knowledge to create new fast-acting antidepressants.

We may not know exactly what is going on, but there are theories about what impact ketamine is having on the brain that may be behind its mental health benefits.

Traditional antidepressants influence neurotransmitters, signaling chemicals like serotonin, which we know play a role in how our brains work. But ketamine seems to be working on the brain in a different way, in part by causing it to regrow synaptic connections, animal data suggests.
These restored connections may be increasing the plasticity of the brain, allowing us to lay down new neural pathways.

Ketamine is not a silver bullet and not without risks of its own, however; it does have the potential for abuse, as years of recreational use have shown.

Since the discovery of ketamine therapy for depression, the drug’s been looked at as a possible treatment for other conditions as well, including OCD, PTSD, and alcoholism.

But the strongest research supports ketamine therapy as a depression treatment, and there’s one thing the drug has going for it that gives it an advantage over other psychedelic therapies.

“And because it was FDA approved in 1970 as a safe, efficacious medicine, that means today it is legally prescribable,” Beynon says.

Ketamine Therapy

Because of that basic legality and the increasing acceptance of ketamine’s potential as a depression treatment, ketamine therapy clinics have begun popping up around the country.

These typically provide ketamine infusion therapy. After medical and mental health screening and sessions with therapists designed to prepare patients for their trips, they receive an infusion of ketamine and go through their psychedelic experience.

“People should expect to feel an alteration in their consciousness that may feel quite profound,” Melanie Malloy, clinical director of Ember Health’s Brooklyn Heights clinic, previously told Freethink.

“They may feel detached from reality, they may stop feeling that they are in their bodies. They will almost certainly feel a distortion of their time sense, a distortion of place, so that sometimes people feel like they’re underground, or underwater, or in space, or having a very vivid recollection of their childhood home.”

Mindbloom patients take physician-prescribed ketamine at home, after preparation sessions. Once the sublingual ketamine is administered, guided music and meditation helps patients through their experience.
The research thus far suggests that the trip alone is not enough for lasting mental health benefits.

Integration sessions, where patients can talk through their experiences, analyze what they’ve learned about themselves, and figure out how to carry those changes into their life, are crucial to psychedelic therapy’s efficacy — something that seems to hold true across other psychedelics, as well.

Mindbloom’s ketamine therapy offerings are taken in the home, with clinician-prescribed remote integration sessions held every 1-2 weeks.

The future of mental health

As the rules and regulations around psychedelics loosen, psychedelic therapy is moving from scientific research to a clinical industry, with the potential to impact actual patients.

“Psychedelic therapy, for me, helped catalyze a fundamental transformation, where I was able to connect with other people, connect with humanity as a whole, and shift from being a pessimist to an optimist,” Beynon says.

 

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How Ketamine’s neurological functions make it a promising psychedelic for psychotherapy

Psychedelic Times

When ketamine was first synthesized in 1962 by chemist Calvin Stevens, psychotherapy was far from his mind. Rather, Stevens was on a quest to create a medicine that met the standards for an ideal anesthetic—one that had a quick onset, reliable effects, minimal consequence on the cardiovascular and respiratory systems, a relatively short duration, and was easy to administer. He found it in ketamine, and the medicine quickly made its way into emergency rooms and onto battlefields in the 60’s and 70’s, where it allowed injured people to move to operation in a dream-like state. Indeed, ketamine seemed to have the unique ability to almost remove a person from their body and their environment while still remaining conscious.

It wasn’t until later that ketamine’s psychoactive properties were discovered, but in hindsight, you could make the case that the psychedelic and empathogenic qualities of ketamine were key to the medicine’s benefits. Unlike other psychedelics, which underwent a research moratorium in the second half of the 20th century, ketamine has a long history of research, but the majority of this has been in the context of its use for anesthesia and analgesia in operation. Only in the last few years has ketamine’s use in a psychotherapeutic context really been explored—particularly for its ability to break depressive episodes. But looking at ketamine’s activity in the brain helps explain its transpersonal qualities and points to its immense therapeutic potential.

Ketamine’s contradictory relationship with glutamate

Compared to other psychedelics like LSD and psilocybin—which increase connectivity between parts of the brain—ketamine takes the opposite approach. Ketamine is the third member of a unique family of chemicals called arylcyclohexylamines, known as dissociative anesthetics, which disrupt the senses and disconnect parts of the brain that regulate consciousness, memory, and emotion. The activity of the neurotransmitter glutamate plays a key role in this, but what we’ve long believed about ketamine—that it simply decreases glutamate transmission—may be more complicated than we thought.

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Blocking glutamate at NMDA receptors

Ketamine blocks NMDA receptors in the brain from being activated by glutamate, preventing the message from being passed between cells. Even though ketamine causes a spectrum of neurological activity, this blocking of the NMDA receptors is ketamine’s primary function—it’s what causes its dissociative, hypnotic, and anesthetic effects. In other words, it makes you feel disconnected from your body and your environment.

A closer look at the disconnected parts of the brain—the thalamus, cerebral cortex, and limbic systems—gives us a clue as to why ketamine acts the way it does:​
  • The thalamus sends sensory and motor signals to the cerebral cortex, regulates consciousness, sleep, and alertness.​
  • The cerebral cortex affects memory, attention, perception, awareness, thought, language, and consciousness.​
  • The limbic system regulates emotion, behavior, motivation, the formation of memories, and olfaction.​
Disconnecting these systems induces a trance-like state similar to what one might experience in a sensory deprivation tank and is described by patients with words like “floating” or “dreamy.” In clinical terms, this state is called conscious sedation. Blocking the NMDA receptor causes patterns in the brain associated with psychedelic experiences, particularly visions and ego dissolution.

It makes sense that a substance with both strong anesthetic and dissociative properties would be particularly helpful for people suffering from anxiety or depression due to chronic pain because it gives a physiological respite from the pain and temporarily disconnects you from negative emotions. This gives ketamine “interrupting” properties—similar to how ibogaine is an addiction interrupter—and makes it a promising treatment for mood disorders.

Increasing Glutamate at AMPA Receptors

Interestingly, while ketamine blocks glutamate from activating NMDA receptors, research now shows that ketamine actually increases transmission of glutamate neurotransmitters, but at other receptor sites called AMPA receptors. So why is it important that NMDA receptors are blocked but AMPA receptors activated? Scientists are still trying to parse this out, but we know that overstimulation of NMDA receptors can cause nerve damage due to increased calcium ions in the brain—it’s this respite from NMDA activity that lends ketamine its neuroprotective qualities. On the other hand, AMPA receptors require less glutamate to be activated and do not allow calcium ions to flow through. When ketamine causes AMPA receptors to be activated, it increases glutamate in the anterior parts of the cingulate cortex, which regulate emotion—this part of the brain helps you assign emotions to internal and external stimulation, regulates your perception of pain, and initiates motor movement. While blocking glutamate at the NMDA receptors may help disconnect you from normal emotional patterns, increasing glutamate at the AMPA receptors may help you associate positive feelings with your ketamine experience.

Regulating opioid and dopamine activity

In addition to its effects on neurotransmitters, ketamine also regulates opioid and dopamine activity in the brain. Activating mu-opioid receptors in the brain—similar to how opiates work—adds to ketamine’s analgesic and anxiolytic effects and increases the psychoactive effects at high doses. Increasing dopamine—similar to amphetamines and NRI antidepressants—mediates the stimulant and euphoriant effects associated with ketamine.

The combination of this activity essentially helps relieve pain and anxiety, and causes a sense of euphoria. While these effects aren’t inherently psychoactive on their own, they ease and mediate the psychoactive properties of ketamine, making it a powerful possibility for treating depression, anxiety, PTSD, and other long-standing mental illnesses.

Using ketamine to break the cycle of mental illness

Ketamine works by essentially giving you a break from daily life—it takes you out of your normal-functioning brain and allows you to gain a different perspective. For people living with mood disorders like chronic depression, PTSD, anxiety, and bipolar disorder—particularly the kind that stems from physical pain or illness—this can offer a needed respite from the pain of day-to-day living.

Perhaps most exciting for people suffering from mood disorders is that ketamine is the only legally available psychedelic in the U.S.—you can get an off-label prescription from your doctor and visit a ketamine clinic where they’re available. Whereas other psychedelics are listed as Schedule I substances, ketamine is Schedule III, which means the DEA recognizes it has medicinal or therapeutic properties. This is particularly helpful for people who don’t want to go through the legal hoops associated with most psychedelic therapy.

If you’re interested in using ketamine to treat a mood disorder, it’s important that you visit a certified clinic that can help you identify the proper dose and administration for your own needs. Going to a certified clinic also opens the door to a mindful integration practice after you’ve been treated, which is key to lasting health. A certified coach, therapist or clinician can help you sort through your experience as well as the long-standing symptoms of your mood disorder. When used responsibly and in a proper setting, ketamine can provide immediate relief and help you take the first step toward recovery.

*From the article here :
 
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Ketamine can quickly ease tough-to-treat depression*

by Amy Norton | HealthDay | 27 Dec 2021

Ketamine, once most famous as a "club" drug, can rapidly improve hard-to-treat depression and curb suicidal thoughts, a new review confirms.

In recent years, ketamine has emerged as something of a wonder drug for some people who do not get better with standard antidepressants.

For those patients, who may have tried multiple conventional medications, ketamine can quickly ease depression symptoms -- even within a day. Experts say that speedy response is especially critical for people at risk of self-harm.

The new review, published recently in the British Journal of Psychiatry Open, pulls together all published research on ketamine as a treatment for psychiatric disorders. And it found that for treatment-resistant depression and suicidal thoughts, the drug can have quick, "robust" effects -- albeit short-lived.

"It is important to emphasize the drug doesn't work for everyone," said senior researcher Celia Morgan, a professor at the University of Exeter in England.

Nor is ketamine simple to take. It has to be given under medical supervision, Morgan noted, so doctors can watch for "dissociative" effects -- or what lay people might call a "trip."

The drug is not a psychedelic, but typically triggers altered perceptions of reality, such as hallucinations, soon after it's given. It can also cause a short-term spike in blood pressure, Morgan said.

So before anyone tries ketamine for depression, she said, they have get a full medical and psychiatric evaluation to make sure it is appropriate for them.

Ketamine was first approved in the United States decades ago as an anesthesia drug. Because of its mind-altering effects, it also came to be abused as a party drug, known by such nicknames as "special K."

But researchers have long been aware of the drug's potential, at low doses under well-controlled conditions, to treat psychiatric symptoms. Ketamine is not approved by the U.S. Food and Drug Administration for treating depression. But doctors can and do prescribe it "off label" for that reason.

And in 2019, the FDA approved a ketamine derivative -- called esketamine (Spravato) -- for depression that has not responded to at least two standard antidepressants.

Unlike ketamine, which is given by IV, esketamine is a nasal spray. But it still must be given under medical supervision, because it has the same side effects.

Since esketamine is FDA-approved for depression, it has become the more practical choice over ketamine, according to psychiatrists not involved in the review.

"It's much easier to get insurance coverage for esketamine," said Dr. Paul Nestadt, co-director of the Johns Hopkins Anxiety Disorders Clinic in Baltimore.

So while he has been involved in ketamine research, Nestadt said that in practice, he is prescribing esketamine.

It's not entirely clear how either drug so rapidly eases depression. But researchers know ketamine has different brain targets than standard antidepressants, and that includes boosting activity in a chemical called glutamate, which helps brain cells communicate with each other. Studies also suggest ketamine fosters the regrowth of synapses -- connections among brain cells that can be depleted in people with longstanding depression.

"With esketamine," Nestadt said, "there is a set treatment protocol: It's used in combination with a standard antidepressant, starting with two doses per week for the first month, then one weekly dose for the next month, and tapering further thereafter."

"The length of that maintenance period, though, is undefined,"
said Dr. Joshua Berman, an assistant professor of psychiatry at Columbia University Irving Medical Center in New York City.

In the earlier years of research, he noted, the focus was on understanding ketamine's rapid effects.

"We, collectively, had never seen anything like it," Berman said.

Now, the ongoing research question is, how long do the antidepressant effects truly last?

It's also unclear, according to the review, whether ketamine helps with other psychiatric disorders, like post-traumatic stress disorder, obsessive-compulsive disorder and drug dependence.

The researchers examined 89 published studies, some of which tested ketamine for those conditions in the short term. But while there were some "positive" effects, Morgan's team said, the results should be interpreted with caution at this point.

For people with depression, both Berman and Nestadt emphasized the importance of a full psychiatric evaluation, along with a medical history, before starting ketamine or esketamine.

There are ketamine "clinics" popping up around the United States, but some are run by anesthesiologists, not mental health professionals.

"Ketamine is not a first-line therapy for depression," Nestadt stressed. "You want a good evaluation first, and you should start with treatments that have been studied for decades."

In addition, Nestadt said he keeps patients on their current treatment -- antidepressants as well as talk therapy -- during the esketamine intervention. And while the maintenance phase of esketamine is not clearly defined, neither it nor ketamine is meant to be given "indefinitely," Nestadt said.

Berman pointed to an additional reason to be under the care of a mental health professional: If ketamine does not work, patients should have other options presented to them.

*From the article here :
 
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In-home Ketamine therapy service launched in San Francisco, Sacramento*

EHAVE | 15 Feb 2022
  • KetaDASH will provide ketamine therapy for the treatment of mental health disorders​
  • KetaDASH is a managed service organization focused on the psychedelic sector with the mission of helping physicians streamline their practice operations, create new revenue opportunities, and achieve better patient outcomes.​
  • KetaDASH treatments will be conducted by a team of experienced physicians, therapists and nurses whom after an initial telemedicine visit will come to your home, office, or mobile location and provide a complete ketamine treatment experience, with a focus on safety, setting, comfort and efficacy of treatments.​
  • Treatment packages include initial telemedicine visit and follow up integration via telemedicine with ketamine experienced psychotherapists.​
Ehave, Inc., a leading healthcare services and technology company, announced today that its wholly-owned subsidiary, KetaDASH, commenced clinical operations, offering in-home ketamine therapy to patients suffering from treatment-resistant mental health issues. Initially, the treatment will be offered in the San Francisco Bay Area and Greater Sacramento Area with plans to expand to other markets in the coming months. KetaDASH is a managed service organization focused on the psychedelic mental health sector with the mission of helping physicians streamline their practice operations, create new revenue opportunities, and achieve better patient outcomes.

KetaDASH treatments will be conducted by a team of experienced nurses who will come to your home, office, or mobile location after initial telemedicine screening and provide a complete ketamine experience, with a focus on set and setting, with packages that include telemedicine integration with psychotherapists. This innovative service departs from in-clinic intravenous, treatment or unsupervised telehealth models to an at-home ketamine administration with telehealth and in-person medical supervision. A typical KetaDASH experience incorporates a prescribing doctor, a nurse for administration and monitoring, and psychotherapists for integration, all from the comfort of the patient’s home.

Jeffrey D. Kamlet, MD, FASAM, DABAM, Chief Medical Officer of Ehave, said, “I have over-seen over 600 successful ketamine treatments and have been amazed by the positive results. We are pleased to begin our U.S. rollout in Sacramento and San Francisco, with plans to scale our business in other cities over the coming months. Even though ketamine is a relatively safe drug to administer, we have made patient safety our top priority. As such, KetaDASH treatments begin with a telehealth med screen and then treatments will be conducted by a team of experienced nurses who will come to your home, office, or mobile location and administer your session. Post ketamine therapy will be available and is recommended. We believe this will give our clients the confidence in knowing they are receiving the utmost support throughout their treatment experience. This pioneering approach is a departure from ketamine telehealth models, which mail prescriptions and do not provide in-person support or guidance during the psychedelic experience.”

Ketamine therapy has turned out to be a life-changing alternative to antidepressants for many patients. MAPS claimed “There has been a recent explosion of interest in ketamine, a synthetic chemical with powerful antidepressant and visionary properties.”

Ketamine is an FDA approved drug that has been used for over 50 years as a safe dissociative anesthetic that is now being studied as a treatment for major depression. In certain psychiatric conditions, such as treatment-resistant depression, anxiety, post-traumatic stress disorder and alcohol abuse, ketamine has shown very encouraging results.

Completing day-to-day activities are often challenging for patients with mental health disorders. For patients who suffer from depression and post-traumatic stress disorder, symptoms such as fatigue, social isolation, lack of motivation, and high levels of anxiety are frequent. Unfortunately, many of the patients who suffer from these mental health issues find it difficult to go to a physical clinic. By providing this treatment at the patient’s home, office, or mobile location, KetaDASH intends to broaden access to this important therapy.

Ben Kaplan, CEO of Ehave, said, “For patients with mental health disorders, the need for more effective treatment options is greater now than it ever has been in the past. When used at sub-anesthetic doses, ketamine has proven effective in treating many psychiatric disorders. KetaDASH will provide better access to this treatment for a larger patient population in a safe and convenient way. Through our KetaDASH mobile clinics, patients will benefit from receiving the ketamine therapy in the privacy and comfort of their own homes. Patient safety is our top priority, so all ketamine treatments will be delivered by certified medical professionals. The KetaDASH platform will utilize proprietary software developed by Ehave which will allow patients and their associated nurses to view detailed reports on the ketamine therapy’s progress.”

KetaDASH is also available to ketamine clinics and qualified patients whose healthcare provider has prescribed it as a treatment. Qualified patients, doctors, and clinics are invited to visit KetaDash.com for more information.

*From the article here :
 
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Why Ketamine Is a Speedster Antidepressant

Ketamine’s rapid action as an antidepressant is a result of increasing the activity of a small number of newborn neurons.
Northwestern University | Neuroscience News | 1 Jun 2022

Ketamine is the speedster of antidepressants, working within hours compared to more common antidepressants that can take several weeks. But ketamine can only be given for a limited amount of time because of its many side effects.

Now, a new Northwestern Medicine study identifies for the first time exactly how ketamine works so quickly, and how it might be adapted for use as a drug without the side effects.

The study in mice shows ketamine works as a rapid antidepressant by increasing the activity of the very small number of newborn neurons, which are part of an ongoing neurogenesis in the brain.

New neurons are always being made at a slow rate. It’s been known that increasing the number of neurons leads to behavioral changes. Other antidepressants work by increasing the rate of neurogenesis, in other words, increasing the number of neurons. But this takes weeks to happen.

By contrast, ketamine produces behavioral changes simply by increasing the activity of the existing new neurons. This can happen immediately when the cells are activated by ketamine.

“We narrowed down the population of cells to a small window that is involved,” said lead study author Dr. John Kessler, a professor of neurology at Northwestern University Feinberg School of Medicine and the Ken and Ruth Davee Professor of Stem Cell Biology.

“That’s important because when you give ketamine to patients now, it affects multiple regions of the brain and causes a lot of adverse side effects. But since we now know exactly which cells we want to target, we can design drugs to focus only on those cells.”

The side effects of ketamine include blurred or double vision, nausea, vomiting, insomnia, drowsiness and addiction.

The study was published recently in Nature Communications.

Goal to develop faster-working antidepressant

“The goal is to develop an antidepressant that doesn’t take three to four weeks to work because people don’t do well during that period of time,” Kessler said. “If you are badly depressed and start taking your drug and nothing is happening, that is depressing in itself. To have something that works right away would make a huge difference.”

Newborn neurons act like a match to ignite activity in neurons

“We prove neurogenesis is responsible for the behavioral effects of ketamine,” Kessler said. “The reason is these newborn neurons form synapses (connections) that activate the other cells in the hippocampus. This small population of cells acts like a match, starting a fire that ignites a bunch of activity in a lot of other cells that produce the behavioral effects.”

“However, it has not been understood that the same behavioral changes can be accomplished by increasing the activity of the new neurons without increasing the rate at which they are born,”
Kessler said. “This obviously is a much more rapid effect.”

For the study, Northwestern scientists created a mouse in which only the very small population of newborn neurons had a receptor that allowed these cells to be silenced or activated by a drug that did not affect any other cells in the brain.

"Scientists showed if they silenced the activity of these cells, ketamine didn’t work anymore. But if they used the drug to activate this population of cells, the results mirrored those of ketamine. This showed conclusively that it is the activity of these cells that is responsible for the effects of ketamine," Kessler said.

Original Research: Open access.
Ketamine activates adult-born immature granule neurons to rapidly alleviate depression-like behaviors in mice” by John Kessler et al. Nature Communications

 
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Who should try ketamine therapy? What does it feel like?

The hype around psychedelic drug therapy has put the spotlight on ketamine. We answer 10 common questions.

by Rachel Zimmerman | Washington Post | 12 Sept 2022

Ketamine is an anesthetic used to sedate both humans and pets, and it’s a favorite of partygoers seeking a psychedelic high. Now it’s also the subject of an enormous amount of interest as a fast-acting treatment for depression and other serious mental health conditions.

Despite all the buzz about ketamine’s therapeutic potential, people remain confused about how it works and how to find a doctor who prescribes it. We interviewed psychiatrists, other experts and patients to answer 10 common reader questions about ketamine. Here’s what they had to say.

Who is most likely to benefit from ketamine therapy?

Ketamine treatment, in general, is for people suffering from serious mental illness who have tried other medications with little or no relief. It has been most widely studied in people with treatment-resistant depression and acute suicidality. It may also benefit patients with conditions such as PTSD, OCD, bipolar depression, anxiety and eating disorders. People with certain conditions such as psychosis generally are not candidates for therapeutic ketamine.

On Monday, a study published in the Journal of Clinical Psychiatry of ketamine users at three clinics in Virginia showed significant reduction in symptoms of depression. The evaluation of more than 400 patients at three MindPeace ketamine clinics in Virginia showed that 72 percent of patients saw improvement in their mood and 38 percent were symptom-free after 10 infusions. The study, conducted by the ketamine clinics on a self-selecting group of patients, has its limitations.

Ketamine was approved as an anesthetic in 1970, but using it to address psychiatric conditions is considered “off-label.” That means it’s legal for a doctor to prescribe, but it’s not approved by the Food and Drug Administration for that particular indication.

The one exception is esketamine, a nasal spray approved by the FDA in 2019, and marketed as Spravato for treatment-resistant depression and acute suicidal thinking.

In biggest advance for depression in years, FDA approves novel treatment for hardest cases

Gerard Sanacora, a professor of psychiatry at the Yale School of Medicine, said that while ketamine can be “lifesaving” for some patients, many questions remain about the range of disorders it might help, the best mode of delivery, optimal dosing and long-term safety. “It’s not a miracle treatment for everyone,” he said.

What is the evidence that ketamine therapy works?

Numerous studies show that ketamine can work as a fast-acting antidepressant, alleviating symptoms in many patients in a matter of hours or days. While no long-term data are available, in early small studies, ketamine therapy significantly and rapidly reduced depression symptoms in about 50 to 70 percent of patients. Traditional antidepressants can take four to six weeks to take effect, and for some patients, they don’t work at all.

While traditional antidepressants can affect levels of certain brain chemicals related to mood and emotion, ketamine influences a different neurotransmitter called glutamate. Ketamine can trigger a cascade of biochemical, structural and functional changes in the brain. It’s believed that ketamine works by essentially making the brain more malleable and receptive to therapy or alternate ways of thinking.

Other psychedelic drugs, including psilocybin, the active ingredient in “magic” mushrooms and LSD, as well as MDMA, known as ecstasy, are being studied to treat various mental health conditions, but esketamine and ketamine currently are the only drugs of this kind that can be prescribed legally outside clinical trials.

Psychedelics may ease cancer patients’ depression, anxiety

What happens during ketamine therapy?

Ketamine therapy often is given through intravenous infusions that last about 40 minutes. The dose is lower than when the drug is used for sedation. Intramuscular injections and tablets that dissolve under the tongue also are becoming more widely used. The nasal spray esketamine is taken along with an oral antidepressant.

In a clinical setting, ketamine patients typically sit in a comfortable chair, listening to music while the treatment is administered. The number of ketamine sessions can vary, but many providers suggest an initial course of six treatments over two to three weeks. Talk therapy, which often happens after the drug effects end, can also be part of the treatment.

Esketamine (Spravato) is given twice a week for the first month and may be taken once a week for a second month. The patient remains under doctor supervision for two hours after treatment until any potential side effects have passed.

What does ketamine therapy feel like?

Patients say that therapeutic ketamine can feel like floating outside one’s body, pleasantly leaving your physical self behind. Some people gain a heightened sensory awareness; colors may seem brighter.

Ann McGill, 67, of Randolph, Mass., who has suffered enduring, debilitating depression, compared her intranasal ketamine treatments to being inside a lava lamp. “Like that little thing that floats around,” said McGill, who received ketamine therapy at McLean Hospital in Belmont, Mass. “It’s really peaceful and serene, tranquil and beautiful.”

Other patients might start crying uncontrollably or become anxious. Common side effects can include nausea, drowsiness, dizziness, poor coordination and feelings of disassociation and unreality. An increase in blood pressure can also occur, which is why monitoring during treatment is important.

Ketamine appears to provide patients a kind of mental time out from distressing thought patterns, experts said. Daniel Brenner, a psychiatrist and founder of Cambridge BioTherapies, said that as negative thinking begins to quiet down during and after ketamine therapy, many patients begin to find psychotherapy more productive, and behavioral patterns easier to rework. “Feelings become more available,” Brenner said. “It’s not just an antidepressant, it’s also a medication that shuts down the anti-reward circuitry in the brain that gives rise to shame and self-reproach and the desire to hurt yourself.”

Ketamine, a new antidepressant, has been blowing minds for decades

Ariel Wolff, a 32-year-old veterinary technician of Malden, Mass., sought treatment from Brenner and began intravenous ketamine infusions in June. After six treatments, Wolff, who had struggled with depression and anxiety for 20 years, started cooking, hiking, reading and chatting with work colleagues again. “I felt great, better than I ever had in my whole life,” she said. “This was the person I’d always wanted to be, but couldn’t because I was so mentally ill.”

In the study at the ketamine clinics in Virginia, researchers found an 85 percent decrease in suicidal ideations, but acknowledged that there is no system to track adverse events and side effects among ketamine patients.

Is ketamine safe?

When used under supervised conditions and with careful patient screening, most practitioners consider therapeutic ketamine to be generally safe, with the caveat that all medications carry some risks. They note that ketamine remains a controlled substance regulated by the Drug Enforcement Administration and is subject to strict safety controls because of its potential for abuse. Certain medications and conditions make ketamine therapy too risky for some patients, physicians say, so a full mental health and medical history is critical before embarking on such treatment.

The American Society of Ketamine Physicians, Psychotherapists & Practitioners advises people “not to drive, work, care for small children, or engage in stressful tasks for the rest of the day after a treatment.”

An international group of experts on mood disorders last year published a paper in the American Journal of Psychiatry synthesizing the current evidence on esketamine and intravenous ketamine for managing treatment-resistant depression. They noted that the drugs offer “opportunity and hope” to patients, but that there is an “urgent need to clarify the long-term efficacy of these agents as well as significant unanswered questions with respect to safety.”

How can someone get a ketamine prescription?

Find a trusted physician or mental health care provider and talk to them about the risks and benefits of therapeutic ketamine. ASKP3, the society of ketamine physicians, estimates there are about 600 providers in the United States offering ketamine to treat thousands of people for a vast array of mental health conditions.

Rakesh Jain, a psychiatrist in Austin, said ketamine therapy in recent years “has become exceedingly common among both psychiatric and non-psychiatric professionals.” The upside, he said, is “thousands of previously poorly treated patients are obtaining relief.” But the number of providers “is so large, and growing so rapidly, there is simply no way to quantify how many clinicians are utilizing therapeutic ketamine in their practices.”

Can people self-medicate with ketamine?

A person considering ketamine treatment will get the best results spending time talking through the various options with a trusted provider or clinician, said Raquel Bennett, a Berkeley-based psychologist and founder of the KRIYA Institute for ketamine research.

Experts strongly advise against self-medicating with ketamine because it can have physical and psychological side effects, and unmonitored patients can develop a dependency over time.

Psychologically, ketamine can trigger a revisiting of traumatic events, and physicians say oversight is important should patients require support or guidance.

If ketamine works, why isn’t everyone with depression using it?

Ketamine’s potential as a treatment for certain mental health conditions is gaining credibility among many physicians. But ketamine is a widely available generic drug, and there’s no incentive for a pharmaceutical company to fund a large, high-quality trial. Ketamine’s reputation as a party drug, the fact that it remains a controlled substance, and the lack of long-term data makes some practitioners and patients wary.

Nothing seemed to treat their depression. Then they tried ketamine.

Are ketamine spas legal? Is at-home ketamine therapy an option?

Physicians can legally prescribe ketamine for mental health conditions, but at the moment, there are no universally accepted requirements for oversight or patient guidelines. As a result, ketamine providers of all flavors have proliferated, from high-end wellness centers wooing clients with zero-gravity chairs and relaxation moon pods to mail-order ketamine subscriptions that come with “healing playlists.”

Albert Garcia-Romeu, an associate professor at Johns Hopkins University School of Medicine, who studies psilocybin and other psychedelic drugs for mental health, describes the ketamine therapy landscape as “kind of the Wild West.” “You pay out of pocket, there’s no real standard protocol, different providers do it differently,” he said. “Some people use it with wraparound talk therapy, others don’t — they just lay you in a bed, do the treatment, then you go home.”

Numerous telehealth companies — Peak, Nue.life and My Ketamine Home, among them — offer ketamine treatment directly to the doorstep. Mindbloom, a telemedicine company launched in 2018, now offers at-home ketamine therapy with virtual support to patients in 30 states, says CEO Dylan Beynon. Consumers are instructed to place the ketamine tablet under their tongue without swallowing for seven minutes and then spit, while a “peer treatment monitor” — an appointed adult coached by a Mindbloom “guide” — stands by.

Some providers worry about the lack of in-person clinician monitoring. “There’s clearly a need for greater oversight,” said Robert Meisner, founding medical director of the ketamine service in the division of psychiatric neurotherapeutics at Harvard’s McLean Hospital.

How much does ketamine therapy cost? Will insurance pay for it?

On average, a single ketamine infusion costs about $450-$500, said Sandhya Prashad, medical director at Houston Ketamine Therapeutics and president of ASKP3, the society of ketamine physicians.

Six ketamine infusions over two to three weeks at a psychiatrist’s office, including an in-depth, pretreatment consultation and post-treatment follow-up, can run up to $4,500. At-home ketamine businesses typically offer the therapy at a lower price point: Mindbloom, for instance, charges $1,158 for a six-session treatment plan with virtual support; it’s $768 for six follow-ups. While some people achieve remission after one round of treatment, some others require monthly boosters.

"Ketamine is a treatment, not a cure,” said Prashad. “Ongoing treatment is very likely required.”

In general, insurance covers Spravato for mental health, but not other forms of ketamine. There are some exceptions. Blue Cross Blue Shield of Massachusetts covers ketamine but requires prior approval and rigorous criteria for use. In some cases, providers say, insurers that won’t reimburse for ketamine treatment might cover some of the related services, so it’s worth checking the details of particular plans.

 

LucidSDreamr

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I might be biased seeing as how this drug destroyed my life.

But psychedelic medicine when the drug is as addictive as any hard drug outthere just seems like we're gonna repeat the same mistake we made with oxycodone...handing out a super addictive drug to for minor problems, overprescribing to cash in....and a generation of peole that got a taste of this ultra addictive drug wanting more.

I understand using it as a last ditch effort for a highly suicidal person for which non addictive antidepressants havnt worked...but all these little clinics and companies are giving K for basically nothing, like we were giving bottles of 200 30 mg roxies out to a 19 year old with a sprained ankle

This is going to backfire
 
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