Clinical study evaluates safety and efficacy of methylone in patients with severe PTSD

Reviewed by Lily Ramsey, LLMOct 20 2023

Clerkenwell Health, the modern mental health company specializing in matching patients with cutting-edge psychiatry treatments, today announced that it is taking part in Transcend Therapeutics’ Phase 2 study evaluating the safety and efficacy of methylone in patients with severe PTSD.

The clinical trials, which are being conducted at Clerkenwell Health’s purpose-built facility near Harley Street in London, sees patients administered with methylone – a rapid-acting neuroplastogen which has short-acting and mild psychological effects - and could require less clinician time for administration, making it potentially well-suited for integration into the existing medical system.

PTSD has distressing symptoms including flashbacks, nightmares and numbing, and it is estimated that 1 in 10 people in the UK may develop the condition in their lives.

Meanwhile more than eight million people in England alone are on antidepressants, rising by over a million people in just five years, and only 50% of people receiving psychological therapies move towards recovery. The status quo for mental health treatment just isn’t working, and the NHS is struggling to cope with the pressure.

By rolling out these clinical trials in the UK we hope to contribute to a growing body of research which supports the development of the next wave of innovative treatments for neuropsychiatric diseases.”

Dr Henry Fisher, Chief Scientific Officer, Clerkenwell Health

Blake Mandell, Co-Founder and Chief Executive Officer at Transcend Therapeutics, said:

“We know from a published clinical case series and other research that methylone could hold tremendous promise for the treatment of PTSD. We are grateful to Clerkenwell Health for partnering on this trial, which will provide invaluable data on the efficacy and safety of methylone for PTSD. We look forward to reviewing the results of this study, and ultimately bringing new and more effective treatments to the market for the millions of people globally who suffer from PTSD.”

1 in 10 people in the UK are expected to experience PTSD at some point in their lives. In the UK, that’s around 6,665,000 people who are expected to develop PTSD or C-PTSD, or complex post-traumatic stress disorder, yet it is still an incredibly misunderstood, often misdiagnosed and stigmatized condition.

The symptoms of PTSD include:

• Re-experiencing (including recurrent distressing images, thoughts, dreams or perceptions of the event) 
• Avoidance and numbing (avoiding thoughts, feelings, activities or conversations associated with the trauma; diminished interest or participation in activities, feelings of detachment or estrangement from others) 
• Hyperarousal (including difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance and an exaggerated startle response).

Transcend expects initial top-line data from the open-label portion of the study by the end of 2023. Following completion of the open-label portion of the study (Part A), Transcend will launch Part B, a randomized, double-blind, placebo-controlled, evaluation of methylone with up to 64 patients with PTSD. 

Experts in finding mental health patients and training the specialized therapists needed to deliver new treatments, Clerkenwell Health’s hybrid research and treatment model provides access to treatments still in R&D through clinical trials or approved treatments through an international network of clinics.