First Patients Dosed With Methylone in London in Ground-Breaking Trial to Treat PTSD
Methylone, a psychoactive drug with effects comparable to MDMA, could be an effective treatment for people diagnosed with PTSD
Resistance against conventional talking therapies and medicines means there is significant demand for new and effective treatments for PTSD
London, October 2023 – Patients diagnosed with post-traumatic stress disorder (PTSD) are being given the opportunity to take part in a ground-breaking clinical trial to treat their condition using the compound methylone, with the first 6 of 15 patients having now been dosed in London.
Clerkenwell Health, the modern mental health company specialising in matching patients with cutting-edge psychiatry treatments, has announced a new partnership with Transcend Therapeutics, a biotechnology company developing rapid-acting treatments for neuropsychiatric diseases, to roll out clinical trials using methylone – Transcend’s lead compound for the treatment of post-traumatic stress disorder (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 psychoactive drug with similar effects to MDMA, and Transcend’s lead product candidate. Unlike classic psychedelics, methylone is not a hallucinogenic, has short-acting and mild psychological effects, and could require less clinician time for administration, making it potentially better suited for integration into our existing medical system[1].
Crucially, unlike classic psychedelics, methylone is not a hallucinogenic, has short-acting and mild psychological effects, and could require less clinician time for administration, making it potentially better suited for integration into our existing medical system[2].
Dr Henry Fisher, Chief Scientific Officer at Clerkenwell Health, said:
“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.”
Blake Mandell, Chief Executive Officer at Transcend Therapeutics, said:
“We know that there is enormous demand, especially among rape and sexual assault victims and veterans, for new and effective treatments for PTSD. Partnering with Clerkenwell Health to offer these clinical trials could provide invaluable data on the neuroplastic effects of methylone on the brain. Through partnerships like this we can strengthen our commitment to discovering, developing and delivering the next generation of psychoactive compounds to treat neuropsychiatric illnesses.”
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 stigmatised condition[3].
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).
Clerkenwell Health are looking for patients aged between 18-65 with a current diagnosis of PTSD to take part in the next phase of the study. Patients will have tried at least one treatment unsuccessfully for PTSD – either psychotherapy or pharmacological treatment – and not currently be on any active treatments.
Transcend Therapeutics recently announced receipt of a collaborative grant award with Yale University to support first-of-its-kind preclinical research on methylone. As part of the research, Yale University received a three-year, $1 million grant from the U.S. Department of Defense to conduct preclinical research using state-of-the-art microscopy and behavioural methods to understand the neurobiological mechanism underlying methylone's rapid-acting, long-lasting behavioural and therapeutic effects in PTSD[4].
Experts in finding mental health patients and training the specialised 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.
[1] Letter from Blake Mandell, Co-Founder and CEO, to Transcend Investors, February 2023 – Transcend Therapeutics
[2] Letter from Blake Mandell, Co-Founder and CEO, to Transcend Investors, February 2023 – Transcend Therapeutics
[3] Post Traumatic Stress Disorder stats and figures, PTSD UK
[4] Transcend Therapeutics and Yale awarded U.S. Department of Defense grant to study methylone for PTSD, September 2023 – PR Newswire