A randomised, placebo controlled trial of psilocybin in treatment resistant depression: A feasibility study

This randomised, placebo-controlled trial (n=60) investigates the feasibility of using a single dose of psilocybin (25mg) as a treatment for adults with treatment-resistant major depressive disorder (TRD).

Conducted by King’s College London and South London & Maudsley NHS Foundation Trust, the study aims to measure recruitment rates, dropout rates, and estimate the variance of the primary outcome measure (MADRS) to inform the design of a potential phase III trial. Secondary objectives include assessing clinician- and participant-rated efficacy, safety, and tolerability of psilocybin.

The trial involves adults aged 25-80 who meet specific criteria for TRD and have not responded to conventional treatments. The primary endpoint is evaluated 3 weeks after dosing, and the trial is set to last approximately 3 years and 11 months. The study has received authorisation from the competent authority and a favourable opinion from the ethics committee. Participants will be followed up after the trial’s end, with care transitioned back to their GP or mental health care team.

The study protocol can be found here.

The study is also registered at clinical trials .gov (CTG) as “Psilocybin in Depression Resistant to Standard Treatments (PsiDeR)“

Topic Treatment-Resistant Depression Depression
Compound Psilocybin
Country United Kingdom
Visit trial
Status Unknown status
Results Published No
Start date 22 May 2020
End date 30 December 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 25- 80
Therapy Yes

Trial Details

This trial (n=60), led by King's College London and South London & Maudsley NHS Foundation Trust, explores the feasibility of using a single dose of psilocybin (25mg PO) for treating treatment-resistant major depressive disorder. It targets adults aged 25-80 with specific TRD criteria, assessing recruitment rates, dropout rates, and MADRS variance as primary endpoints. The study, authorized by the competent authority, has a favourable ethics committee opinion and is no longer in the EU/EEA after completion.

Trial Number 2018-003573-97

Sponsors & Collaborators

King's College London
The 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.

South London and Maudsley NHS Foundation Trust
The South London and Maudsley NHS Foundation Trust provide the widest range of NHS mental health services in the UK. The trust has recently expanded its research into psychedelic therapies.

Papers

Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial
This 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.

Data attribution

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