Psilocybin TRD Feasibility RCT
Research type
Research Study
Full title
A randomised, placebo controlled trial of psilocybin in treatment resistant depression: A feasibility study
IRAS ID
252750
Contact name
James Rucker
Contact email
Sponsor organisation
King's College London
Eudract number
2018-003573-97
Duration of Study in the UK
2 years, 11 months, 27 days
Research summary
Major depressive disorder is a burdensome and costly health problem for patients, carers, societies and governments. Resistance to medical and psychological treatments is common and this group are much more likely to be socioeconomically inactive, suffer from comorbid physical health problems and to die by suicide. Despite this, treatment resistant depression is under-researched and no new breakthrough paradigms of treatment have been developed since the introduction of the selective serotonin antidepressants and cognitive behavioural therapy in the 1980s. Combinations of antidepressants and psychotherapy are more effective than either alone. The psychedelic drugs, including psilocybin, were used by psychiatrists prior to prohibition in 1970 for treatment resistant cases of depression, anxiety and addictions. Within a supportive therapeutic context they showed promise in this group, however evidence about safety and efficacy was inconclusive prior to prohibition. Since 2010 a resurgence of interest in this treatment paradigm has occurred. We have completed an uncontrolled, open-label pilot study of psilocybin with psychological support in 20 patients with treatment resistant depression that demonstrated the feasibility of delivering this treatment in this group of patients. The current study is a randomised, placebo controlled trial of psilocybin in up to 60 participants with treatment resistant depression. The objective is to test the feasibility of the randomised, controlled trial design with this drug in this patient group, to collect safety data and to estimate how many participants we would need for a larger, definitive trial.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/0206
Date of REC Opinion
22 May 2020
REC opinion
Further Information Favourable Opinion