Trial of New Psychedelic Drug Seeks Patients with Treatment-Resistant Depression
London, February 2024: A worldwide clinical trial for treatment-resistant depression, using a new psilocybin-like psychedelic substance, has expanded into a new London location – and is seeking suitable candidates.
Clerkenwell Health – a company delivering clinical trials for treatment of complex mental health conditions – has partnered with biotechnology company Beckley Psytech to see if 'novel' psychedelic compound BPL-003 (5-MeO-DMT), which occurs naturally in some animals and plants, can treat the condition.
The trial, which will combine use of BPL-003 with a programme of psychological support, will now go ahead at Clerkenwell Health’s clinic near London's Harley Street – Europe’s first commercial psychedelic facility. It is also taking place at other locations around the world including Australia, Germany, Poland, Spain and the United States.
Suitable patients, who have depression but have not responded adequately to at least two types of anti-depressants, are still needed for the trial. People who are interested can register here.
Most clinical trials using psychedelics have been conducted with long-lasting substances like psilocybin or LSD. However, evidence suggest short-lasting compounds like BPL-003 can be effective in treating serious mental health conditions.
BPL-003 produces psychedelic experiences similar to those felt under the influence of psilocybin, creating transcendental and euphoric feelings without the typical visual distortions. Crucially though, the effects only last between 30 and 60 minutes, whereas the effects of psilocybin can last for up to 6 hours.
Shorter-acting psychedelics could therefore improve the applicability and accessibility of psychedelic treatments in healthcare systems given they require fewer resources and can facilitate greater numbers of treatments.
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.
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.”
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 depression.
The potential of new drugs, such as psychedelic compounds, to effectively treat serious forms of depression could be revolutionary for the UK’s health services and those suffering from depression. Government research suggests the wider economic costs of mental illness in England are an estimated £105.2 billion each year.
This latest randomised, dose-finding trial will evaluate the effects of a medium or high dose of BPL-003 (combined with psychological support), against an active placebo in patients with moderate to severe treatment-resistant depression.
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.