Trial of new psychedelic drug seeks patients with Treatment Resistant Depression

London, Feb. 07, 2024 (GLOBE NEWSWIRE) -- An international clinical trial which is investigating a novel synthetic formulation of the psychedelic substance 5-MeO-DMT (also known as Mebufotenin) for Treatment Resistant Depression (TRD) has expanded into a new London location – and is seeking suitable candidates.

Clerkenwell Health – a company delivering clinical trials for the treatment of complex mental health conditions – has partnered with clinical-stage biotechnology company Beckley Psytech to see if BPL-003, the company’s rapid-acting and short-duration formulation of 5-MeO-DMT, can treat the condition.

The trial, which will explore the effects of a low, medium or high dose of BPL-003, alongside psychological support from trained study therapists, will now go ahead at Clerkenwell Health’s clinic near London's Harley Street – Europe’s first commercial psychedelic research facility. It is also taking place at other locations around the world including Australia, Germany, Poland, Spain and the United States, and is thought to be the largest ever controlled study to investigate 5-MeO-DMT.

Suitable patients, who have depression but have not responded adequately to at least two types of antidepressants, are needed for the trial. Patients who are interested can register here.

Most clinical trials using psychedelics have been conducted with substances like psilocybin or LSD which elicit psychedelic effects that can last up to 6 hours. However, evidence suggests that short-duration, fast-acting compounds like BPL-003, which can produce psychedelic experiences that last between 30 - 60 minutes, can be effective in treating serious mental health conditions.

Shorter-acting psychedelics could therefore improve the applicability and accessibility of psychedelic treatments in healthcare systems, lowering the resource burden on healthcare systems and facilitating a greater number of treatments.

Dr Henry Fisher, Chief Scientific Officer at Clerkenwell Health, said:

“A combination of talking therapy and antidepressants has long been considered the only available course of action for people suffering from Treatment Resistant Depression. This prevailing view is now changing, with new clinical research and trials exploring new approaches to treatment.

“This trial – open to people whose condition has demonstrated an inadequate response to at least two antidepressant therapies – will help improve our understanding and pave the way for the development of effective new approaches. We urge anyone who thinks they may be eligible to apply for the trial.”

Dr Rob Conley, Chief Medical and Scientific Officer at Beckley Psytech, added:

“With around 100 million around the globe living with Treatment Resistant Depression, the urgent and unmet need for more effective therapies is profound. We are proud to be at the forefront of this critical area of study, conducting the world’s largest clinical study of 5-MeO-DMT in order to evaluate whether our fast-acting, short-duration formulation might provide real and sustained relief to those living with this difficult condition.”

Around 1 in 6 UK adults in the UK are affected by depression. Evidence suggests up to a third of those can be categorised as having Treatment Resistant Depression. Current treatment options for depression normally involve talking therapy, such as cognitive behavioural therapy (CBT) and antidepressants (SSRIs). However, little progress has been made in the last 50 years in developing new areas of pharmaceutical or treatment types for the condition.

A growing body of research suggests psychedelic drugs could be a pioneering force in the treatment of complex mental health conditions. The combination of specialised psychological support sessions alongside the administration of a psychedelic compound could lead to a paradigm shift for the treatment of complex mental health conditions.

The potential of new drugs, such as psychedelic compounds, to effectively treat serious forms of depression could also be revolutionary for the UK’s health services. Government research suggests the wider economic costs of mental illness in England are an estimated £105.2 billion each year. 



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