Patients with treatment-resistant depression sought for trial of psychedelic drug

With treatment-resistant depression, standard solutions aren’t enough. They might not make an impact or your symptoms may only improve temporarily.

Now, an international clinical trial​ is investigating a novel synthetic formulation of the psychedelic substance 5-MeO-DMT, also known as Mebufotenin, for Treatment Resistant Depression (TRD). The trial has now 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.

Largest-ever psychedelics controlled study

The trial is also taking place at other locations around the world including Australia, Germany, Poland, Spain, and the United States, and the company says it is thought to be the largest-ever controlled study to investigate 5-MeO-DMT.

Patients who have not responded to treatment adequately which includes trying at least two types of antidepressants are needed for the trial. Interested patients can register here​.

Clinical trials using psychedelics are usually conducted with substances like psilocybin or LSD which induce psychedelic effects that can last up to six hours. Clerkenwell says 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, the company believes, 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.

Inadequate response to antidepressants

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.”

The Office of National Statistics reports that around one in six (16%) adults experienced moderate to severe depressive symptoms; this is similar to rates found in summer 2021 (17%), however higher than pre-pandemic levels (10%).

Evidence​ suggests up to a third of those can be categorised as having TRD. 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.

Research - psychedelic drugs pioneering force

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.”

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. 

According to the National Library of Medicine, a recent resurgence of clinical interest in the use of psychedelics for the treatment of mental disorders is evidenced by a sharp increase in studies and publications. After a decades-long research hiatus, psychedelics have been investigated as potentially effective treatments for several mental disorders, including substance use disorders, post-traumatic stress disorder​, anxiety​, and depression secondary to a life-threatening illness, social anxiety in autistic adults, obsessive–compulsive disorder (OCD), depression, and suicidal ideation.  

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.