The news comes as psychedelics continue to gain scientific recognition as promising new treatments for various mental health disorders.
“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,” Clerkenwell Health chief scientific officer Dr Henry Fisher said.
The trial will be the first in the UK to assess whether the drug, which has been compared to MDMA, could offer a safe treatment for the condition.
The phase 2 study is now underway, with the first patients having just been dosed at Clerkenwell Health’s facility near Harley Street in London.
Participants with PTSD aged between 18 and 70 will receive methylone capsules once a week for 4 weeks, while another group will receive a placebo. After the trial is completed, patients will be monitored for a further 6 weeks.
According to researchers, the drug could require less clinician time for administration, therefore making it well-suited for integration into the NHS.
Methylone belongs to a class of psychoactive drugs called entactogen, which includes MDMA, that can elicit feelings of empathy, emotional openness and make people feel closer to others. However, the drug is short-acting and does not induce hallucinations.
An estimated 1 in 10 people in the UK will experience PTSD at some point in their lives. Symptoms include recurrent distressing images, flashbacks and nightmares of a traumatic event, avoidance and numbness, and hypervigilance. Current treatments include talking therapy and antidepressant medications.
Transcend expects initial top-line data from the open-label portion of the study by the end of 2023.
Following completion of this initial study, the company will launch part b, a randomized, double-blind, placebo-controlled, evaluation of methylone with up to 64 patients with PTSD.
Blake Mandell, CEO and co-founder at Transcend Therapeutics, commented: “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.”
