Psilocybin TRD Feasibility RCT

Randomized, single Blind

This is a randomised, placebo-controlled feasibility study to test trial procedures, collect safety data and estimate sample size for a definitive trial of psilocybin with psychological support in treatment-resistant depression.

Participants meet DSM-5 criteria for major depressive disorder of at least moderate severity and have failed multiple antidepressant treatments; outcomes include safety, feasibility metrics and depressive symptom change (e.g., HAM-D).

Study Protocol

Preparation

sessions

Dosing

sessions

Age 25 - 80 years
Fluent in English
Fulfil DSM-5 criteria for a primary diagnosis of current single or recurrent episodes of MDD of at least moderate severity without psychotic features as defined on the MINI 7.0; positive/primary diagnoses on the MINI 7.0 will be confirmed at clinical interview by a psychiatrist
17-item HAM-D score >= 14
Failed to respond to 2 or more antidepressants at minimum effective dose for >=6 weeks OR at least 1 antidepressant at minimum effective dose for >=6 weeks AND a course of evidence-based psychotherapy of >=6 sessions (defined in protocol)
For participants >=60 years, first episode must have started before their 60th birthday
Able to provide informed consent and comply with study procedures

Diagnosis of bipolar disorder (bipolar I or II) on MINI 7.0
Diagnosis of psychotic disorder on MINI 7.0 (except short substance/medication-induced psychosis limited to intoxication period)
Diagnosis of drug or alcohol dependence syndrome on MINI 7.0
Diagnosis of any personality disorder based on clinical interview and MINI 7.0
Diagnosis of any dementia
Personal history of >=1 suicide attempt in the past year requiring hospitalisation (CSSRS Q6 past year = yes) – will be confirmed at clinical interview
Other personal circumstances or behaviour judged incompatible with safe exposure to psilocybin
Depression secondary to other medical conditions
Medical diagnoses incompatible with psilocybin treatment (see protocol)
Inability to provide screening blood, urine or ECG samples
Clinically significant biochemical abnormalities on labs
Electrocardiographic abnormalities not normal sinus rhythm and deemed clinically significant
Women of childbearing potential not using adequate contraception; pregnant or breastfeeding women excluded
Unable to give informed consent or not registered with a GP or decline sharing GP summary care record
Enrolment in another drug trial

Start: 2020-12-03

End: 2024-02-28

Company

Product

Legal

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details