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Psilocybin therapy for anorexia shows positive results



Transform Drugs releases book: How to regulate psychedelics

A new Phase 1 study looking at psilocybin in combination with psychological support as a treatment for females with anorexia nervosa has shown positive results.

Eating disorders have increased 140% over the last decade, however, treatment for conditions such as anorexia nervosa often falls short of success. With 31% of anorexia nervosa patients experiencing relapse, there is a desperate need for new treatments. 

Now, in the first study of its kind study, published in the journal Nature, researchers have investigated the safety, tolerability and exploratory efficacy of a single 25-mg dose of psilocybin in conjunction with psychological support as a treatment for anorexia nervosa.

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The authors write: “There have been minimal advancements in novel treatment strategies and stagnant outcomes over the past several decades, resulting in a ‘crisis in care’4,5. Novel and innovative treatment methods are urgently needed to improve treatment engagement and outcomes. One such avenue may be psilocybin therapy.”

The results show that the treatment was tolerated by participants with no serious adverse effects observed and no clinically significant changes were observed in vital signs or ECG.

See also  Phase 2 clinical trial to investigate psilocybin for anorexia nervosa 

However, two participants that were required to eat breakfast before the treatment developed hypoglycemia, although this resolved within 24 hours. Additionally, one participant with a history of major depressive disorder (MDD) and suicidal ideation reported an increase in suicidal ideation during the three-month follow-up, however, the researchers note that this did not appear to be related to study participation. 

Mild adverse reactions among participants included headache, nausea and fatigue.

Regarding weight concerns, tests showed that they were significantly decreased from baseline to the one-month and three month follow-ups, and shape concerns also significantly decreased at the one-month. However, the researchers say these were no longer significant at the three-month follow-up. 

Additionally, changes in the eating concern and dietary restraint subscales were not significant, but changes in eating concerns approached significance at the three-month follow-up.

The authors write: “Effects of treatment were, however, highly variable among participants…

“Four participants (40% of sample) demonstrated global EDE scores that decreased to within 1 s.d. of community norms (mean 0.93, s.d. 0.80)34 at 3-month follow-up (Extended Data Fig. 2), which we interpret to be clinically significant. No correlations were observed between any assessed participant characteristics and outcomes. Three of four responders met criteria for AN (versus pAN), and one had a diagnosis of anorexia nervosa binge–purge (AN-BP).”

Dr Trevor Steward, Senior Research Fellow in the School of Psychological Sciences, University of Melbourne, who was not involved with the study, commented: “This study represents an important first step towards determining how safe and well-tolerated psilocybin therapy is for adult patients with anorexia nervosa. 

“It opens the door for the next phase of clinical trials to assess the effectiveness of psilocybin therapy in improving anorexia nervosa symptoms.

“Psilocybin therapy has provided glimmers of hope in other mental health disorders, notably by providing evidence that it can improve anxiety, cognitive flexibility, and self-acceptance for some people. These are all features of anorexia nervosa and the rationale for exploring psilocybin therapy as an option in the case of anorexia is strong. 

“However, this study does not demonstrate that psilocybin therapy can be used to treat anorexia nervosa. Larger-scale clinical trials are a fundamental requirement to confirm whether psilocybin therapy can indeed be considered a viable treatment for anorexia nervosa. 

“While these results show this psilocybin therapy is safe under controlled conditions, it’s essential not to let the hype around psychedelics outpace the scientific evidence. Continued research and caution are of the utmost importance to ensure we make informed decisions about the potential of psilocybin therapy in tackling this deadly illness.

“The field is only beginning to scratch the surface in terms of understanding how psilocybin impacts the brain and dedicated funding to exploring how it specifically acts to target anorexia nervosa symptoms is crucial to advancing this important avenue of research. As there are no approved medications available specifically for anorexia nervosa treatment, psilocybin therapy may prove to be a promising option, though additional research is needed to test this.”

Dr Alexandra Pike, Lecturer in Mental Health, University of York, who was also not involved with the study, said:

“The authors report the results of a small Phase 1 clinical trial of psilocybin (the active ingredient in ‘magic mushrooms’) in 10 people with the eating disorder anorexia nervosa (though some participants were in partial recovery). Notably, Phase 1 trials are not designed to test the efficacy of an intervention on symptoms: instead, a Phase 1 study is performed to assess whether an intervention is safe and tolerable in a sample of the people it might be used in.

“In this small and self-selecting sample, there were no serious adverse events, but two participants experienced a brief period of low blood sugar. The changes found in eating disorder symptoms were very subtle, and only appeared in a few of the many questionnaires participants completed – in contrast to more unambiguous results in disorders such as major depressive disorder. Limitations include the fact that there was no control group, so any improvement might be a ‘placebo effect’, and were self-selecting, so may already have felt positive about psychedelics and expected psilocybin to work.

“Additionally, the protocol includes sessions with psychologists alongside the delivery of psilocybin, which may also have caused effects on symptoms.

“It is also worth noting that two authors (SKP and WHK) have financial and scientific relationships with COMPASS Pathways, the company which manufactures this form of psilocybin. In sum, this study is a first step in showing that psilocybin may be a safe treatment for those with anorexia nervosa, but we cannot conclude from this work that it will be effective in this chronic, complex illness.”

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Mapping the effects of ketamine on the brain



Mapping the effects of ketamine on the brain

A new study has mapped the effects of ketamine on the brain, finding that repeated use over extended periods creates widespread structural changes in the brain’s dopamine system.

The study found that repeated ketamine exposure leads to a decrease in dopamine neurons in midbrain regions linked to regulating mood. They also revealed an increase in dopamine neurons in the hypothalamus, which regulates the body’s basic functions like metabolism and homeostasis.

A former finding that ketamine decreases dopamine in the midbrain, may indicate why long-term abuse of ketamine could cause users to exhibit similar symptoms to people with schizophrenia. 

The researchers suggest that their new finding that ketamine increases dopamine in the parts of the brain that regulate metabolism, published in Cell Reports, may help explain why it shows promise in treating eating disorders.

They suggest this strengthens the case for developing ketamine therapies that target specific areas of the brain, rather than administering doses that wash the entire brain in ketamine.

Raju Tomer, the senior author of the paper, stated: “Instead of bathing the entire brain in ketamine, as most therapies now do, our whole-brain mapping data indicates that a safer approach would be to target specific parts of the brain with it, so as to minimise unintended effects on other dopamine regions of the brain.”

Tracking detailed data

The researchers tracked highly detailed data that enabled them to track how ketamine affects dopamine networks across the brain. 

The insight revealed that ketamine reduced the density of dopamine axons (nerve fibers) in the areas of the brain responsible for hearing and vision, while increasing dopamine axons in the brain’s cognitive centers, which may help explain the dissociative behavioral effects observed in individuals exposed to ketamine.

Malika Datta, a co-author of the paper, added: “The restructuring of the brain’s dopamine system that we see after repeated ketamine use may be linked to cognitive behavioral changes over time.”

Most studies of ketamine’s effects on the brain to-date have looked at the effects of acute exposure – how one dose affects the brain in the immediate term. 

For this study, researchers examined repeated daily exposure over the course of up to ten days. Statistically significant alterations to the brain’s dopamine makeup were only measurably detectable after ten days of daily ketamine use. 

The researchers also assessed the effects of repeated exposure to the drug at two doses, one dose analogous to the dose used to model depression treatment in mice, and another closer to the dose that induces anesthesia. The drug’s effects on dopamine system were visible at both doses.

“The study is charting a new technological frontier in how to conduct high-resolution studies of the entire brain,” said Yannan Chen, paper co-author. 

It is the first successful attempt to map changes induced by chronic ketamine exposure at what is known as “sub-cellular resolution,” in other words, down to the level of seeing ketamine’s effects on parts of individual cells.

Most sub-cellular studies of ketamine’s effects conducted to date have been hypothesis-driven investigations of one area of the brain that researchers have targeted because they believed that it might play an important role in how the brain metabolises the drug. 

This study is the first sub-cellular study to examine the entire brain without first forming such a hypothesis.

Bradley Miller, a Columbia psychiatrist and neuroscientist who focuses on depression, said: “Ketamine rapidly resolves depression in many patients with treatment-resistant depression, and it is being investigated for longer-term use to prevent the relapse of depression. 

“This study reveals how ketamine rewires the brain with repeated use. This is an essential step for developing targeted treatments that effectively treat depression without some of the unwanted side effects of ketamine.”

“This study gives us a deeper brain-wide perspective of how ketamine functions that we hope will contribute to improved uses of this highly promising drug in various clinical settings as well as help minimise its recreational abuse. More broadly, the study demonstrates that the same type of neurons located in different brain regions can be affected differently by the same drug,” added Tomer.

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Psilocybin analogue shows positive results in Phase 2 depression study



Psilocybin analogue shows positive results in Phase 2 depression study

Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).

Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.

CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.

Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.

The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.

The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.

Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.

“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”

Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.

Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.

“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS. 

“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo. 

“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg). 

“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.

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Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research



Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research

Mental health research provider Clerkenwell Health is calling for volunteers to join its groundbreaking clinical trials that will research whether psychedelics can provide effective treatments for complex mental health conditions.

Clerkenwell is seeking a diverse group of volunteers from across the UK between 18 and 65 years old to take part in the trials if they suffer from a relevant condition. 

The trials, which will be conducted at Clerkenwell Health’s purpose-built facility near Harley Street in London, are being run in partnership with a number of world-leading drug developers to test whether psychedelic drugs – often combined with talking therapy – can offer a new approach to treating a variety of mental health illnesses.

See also  Clerkenwell Health is launching a free UK psychedelic therapist training programme

Clerkenwell Health is seeking volunteers for trials that look to find cures for a range of conditions, including PTSD, depression, alcohol use disorder and anorexia. 

Many of the conditions have few successful treatment options and Clerkenwell’s innovative methods of combining psychedelics with therapy aim to to treat these problems more holistically, providing long-term quality of life for patients.

Chief Scientific Officer at Clerkenwell Health, Dr Henry Fisher, said: “With the current system for treating mental health disorders simply not working, we’re calling for patients to help identify the next wave of treatments. 

“These have the potential to be groundbreaking for the millions of people across the UK who are affected by poor mental health.

“The status quo for mental health treatment has not only resulted in patients experiencing debilitating side-effects, huge waiting lists and high relapse rates, but is costly, complicated and broadly ineffective. 

“By participating in upcoming clinical trials, patients have an opportunity to make a valuable contribution to growing research which will support the development of the next generation treatments for mental health conditions.”

According to MIND, approximately 1 in 4 people in the UK will be affected by a mental health condition each year and with a significant rise in people contacting mental health services in recent years, there has never been a more desperate need to identify new and innovative treatments.

Given the challenges facing the country’s health service and with mental health challenges on the rise, the search for volunteers to test effective treatments has never been more pressing. 

Clerkenwell has stated, in this regard, that it has gone national with its search for volunteers in an effort to deliver medical breakthroughs in mental health akin to the Polio clinical trials in the 20th Century.

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