Psilocybin in Depression Resistant to Standard Treatments

Phase 2 Unknown 60 enrolled King's College London South London and Maudsley NHS Foundation Trust · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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).

Timeline

Start: 2020-09-01
Primary completion: 2023-09-01
Completion: 2023-11-01

Publications

Rucker J, Jafari H, Mantingh T, Bird C, Modlin NL, Knight G, Reinholdt F, Day C, Carter B, Young A. Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial. BMJ Open. 2021 Dec 1;11(12):e056091. doi: 10.1136/bmjopen-2021-056091.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Psilocybin	Other / unclassified	25 mg	Oral

Indications

No indication recorded.