Psilodep-RCT
Research type
Research Study
Full title
Psilocybin for major depression: A randomized control trial
IRAS ID
221666
Contact name
David Nutt
Contact email
Sponsor organisation
Imperial College London
Eudract number
2017-000219-18
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The aim of this study is to test the efficacy of psilocybin as an intervention for major depressive disorder (MDD) using a 3-arm double-blind randomised control trial, incorporating an inactive (placebo) and active (escitalopram) comparator arm. A secondary aim is to use functional magnetic resonance imaging (fMRI) to try and identify how the different interventions affect brain activity and whether baseline fMRI parameters can predict responses.
Eligible patients will be randomly allocated to three conditions: 1) a single dosing session with 25mg oral psilocybin followed by 4 weeks of daily placebo ingestion, 2) a single dosing session with 1mg psilocybin (sub-psychoactive) followed by 4 weeks of daily placebo, 3) a single dosing session with 1mg psilocybin followed by 4 weeks of daily escitalopram (commonly prescribed SSRI antidepressant medication), starting at 10mg for the first week and increasing to 20mg for 3 further weeks.
The primary outcome is changes in QIDS-16 scores from pre-treatment baseline to 4 weeks after the psilocybin dosing session. The primary hypothesis is that reductions in QIDS-16 scores from baseline to 4-weeks post-treatment will be greater in the 25mg psilocybin condition (condition 1, above) than in the inactive condition (condition 2, above).
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0389
Date of REC Opinion
21 Nov 2017
REC opinion
Further Information Favourable Opinion