Issue 160

First psilocybin trial for bipolar depression shows promising results

JAMA Psychiatry recently published results from the first-of-its-kind clinical trial conducted at Sheppard Pratt. The study explored the efficacy and safety of a single dose of synthetic psilocybin accompanied by psychotherapy in treating individuals with treatment-resistant bipolar type II disorder (bipolar II).

The 12-week, open-label trial, initiated and led by Scott T. Aaronson, chief science officer of the Institute for Advanced Diagnostics and Therapeutics at Sheppard Pratt, and funded by Compass Pathways, included 15 participants aged 18 to 65 with treatment-resistant bipolar II.

Each participant had experienced an episode of bipolar II for a period greater than three months and documented at least two failed pharmacological treatments within the current episode.

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PATIENTS WITH A TERMINAL DIAGNOSIS WANT TO ACCESS PSILOCYBIN

Drug Science has published a new report featuring calls from patients for Compassionate Access to Psilocybin in the UK.

The patients are calling on the UK government to reconsider psilocybin’s current regulatory status to improve access to therapy.

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MAPS PBC SUBMITS NDA TO FDA FOR MDMA-ASSISTED THERAPY

MAPS Public Benefit Corporation has submitted a New Drug Application to the FDA for MDMA-assisted therapy for PTSD.

The submission is the first-ever NDA for psychedelic-assisted therapy, breaking a milestone for patient access in the US.

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BUSINESS AND INVESTMENT

Gilgamesh Pharmaceuticals is set to initiate a Phase IIa trial investigating GM-2505, a novel 5-HT2A receptor agonist.

Psyched Wellness has confirmed its product Calm – the first legal Amanita Muscaria extract – is on sale in New York. 

Beckley Retreats has announced the expansion of its Scholarship Programme to improve access to psilocybin retreats.

A new partnership between Rose Hill and ACS Labs has been established to improve psilocybin testing standards.

SCIENCE AND RESEARCH

Delix has announced Phase 1 data shows DLX-001 is safe and well-tolerated without producing hallucinogenic, psychomimetic, or dissociative effects.

Binghamton University explores its Professors’ research which takes a detailed look at what constitutes ego dissolution.

Psychology Today takes a look at the science of ayahuasca and its potential promise for mental health treatment breakthroughs.

The Guardian discusses how psychedelics are gaining increased attention from people interested in longevity.

REGULATION AND LEGISLATION

Talking Drugs explores key challenges facing psychedelics, including concerns over the environment, indigenous knowledge and racial disparities.

PBS reports that Kentucky’s Opioid Abatement Advisory Commission is debating on allocating $42 million in funding for therapeutic Ibogaine research.

ARTICLES OF INTEREST

The NHS has provided guidance on care and support for autistic adults to meet their mental health needs.

The EU Parliament has voted in favour of a direct funding initiative to tackle mental health in Europe.

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