Several clinical studies into psychedelics-assisted psychotherapy for treatment-resistant depression are currently going on at Dutch universities, and are still recruiting research subjects.
Three Dutch university medical centers – Groningen, Leiden and Utrecht – are participating in the largest research to date using psilocybin-assisted therapy for treatment-resistant depression. This study, a phase IIb dose-ranging study with 216 patients financed by Compass Pathways, is carried out in a number of sites across North America and Europe, including the Netherlands. If successful, it will be followed by phase III studies, paving the way for the use of psilocybin-assisted therapy as a standard treatment against depression.
These three research sites are still recruiting subjects over 18 years of age who will receive either 1mg, 10 mg or 25 mg of psilocybin in a single session following extensive preparation. Full details regarding study design and admission criteria can be found on the web pages of these research sites (Groningen, Leiden, Utrecht).
For this multisite study, Compass was granted Breakthrough Therapy designation by the FDA. The FDA designates a drug as a Breakthrough Therapy if preliminary clinical evidence shows that it may demonstrate substantial improvement over available therapy. This designation is intended to expedite the development and review of drugs for serious or life-threatening conditions, and it entails more intensive FDA guidance on an efficient drug development program.
More recently, the non-profit medical research organisation Usona Institute also obtained Breakthrough Therapy designation, this time for its psilocybin programme for major depressive disorder, an indication that is broader in scope than treatment-resistant depression. Adding the designation of MDMA as Breakthrough Therapy for post-traumatic stress disorder in 2017, this is the third time in as many years that the FDA gives a psychedelic treatment protocol this kind of organisational and administrative booster, feeding the hope of many that regular prescription of psychedelic treatments may be only a few years away.
In another study in the Netherlands, the department of Psychology and Neuroscience at Maastricht University is testing the effect of a single administration of ‘a naturally occurring psychedelic substance’ on treatment-resistant depression. Previously, the same research team has tested the same compound on healthy volunteers, and the trial is now going into its clinical phase with subjects between 18 and 64 years of age presenting treatment-resistant depression. Full details are available on the Psychopharmacology in Maastricht website.
Elsewhere in Europe, other trials investigating the effects of therapy with psychedelics – mostly psilocybin – on depression, are still recruiting research subjects. In Zurich (Switzerland), dr. Franz Vollenweider’s team is conducting a randomised double-blind placebo-controlled study investigating the effects of psilocybin on major depressive disorder in 60 research subjects. In London, a team at Imperial College’s Centre for Psychedelic Research, led by David Nutt, is testing psilocybin against escitalopram, an SSRI antidepressant, on 50 research subjects with major depression. And also in London, the Centre for Affective Disorders was awarded a large grant from the National Institute for Health Research (NIHR) in 2017 to investigate the safety, feasibility and efficacy of psilocybin as a treatment for treatment-resistant depression. The Centre is starting recruitment of 60 participants for this randomised, placebo-controlled study, which will be led by Dr James Rucker.