A single centre clinical trial to evaluate the feasibility, safety and efficacy of psilocybin, given under supportive conditions, in a randomised, blinded design in adult participants with treatment resistant major depressive disorder.
The primary objective is to evaluate feasibility by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS).
Compound Psilocybin
Placebo
Country United Kingdom
Visit trial
Status
Recruiting
Results Published
Start date
01 September 2020
End date
01 November 2023
Chance of happening
89%
Phase
Phase II
Design
Blinded
Type
Interventional
Generation
First
Participants
60
Sex
All
Age
25- 80
Therapy
Yes
Trial Details
We are recruiting up to 60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD. Participants are randomised to receive a single dosing session of 25 mg psilocybin or a placebo. All participants receive a package of psychological therapy. The primary outcome measure for depression is the Montgomery Asberg Depression Rating Scale collected by blinded, independent raters. The primary endpoint is at 3 weeks, and the total follow-up is 6 weeks. With further informed consent, this study collects neuroimaging and omics data for mechanism and biomarker analyses and offers participants an open label extension consisting of a further, open label dose of 25 mg of psilocybin.NCT Number NCT04959253
Sponsors & Collaborators
King's College LondonThe Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London is one of Europe's top centres for mental health and related neurosciences research.
Papers
Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trialThis paper (2021) lays out the protocol for a randomized, placebo-controlled trial exploring the safety and efficacy of using psilocybin-assisted therapy for the treatment of treatment-resistant major depressive disorder (MDD). Up to 60 participants will be selected and randomized to a single dosing session of 25mg psilocybin or placebo.