Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinPlaceboCompleted

Psilocybin TRD Feasibility RCT

Randomised, placebo-controlled feasibility trial (n=60) testing psilocybin with psychological support in adults aged 25–80 with treatment-resistant depression.

Target Enrollment
60 participants
Study Type
interventional
Design
Randomized, single Blind

Detailed Description

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

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Psilocybin with psychological support (active intervention).

Interventions

  • Psilocybin
    via Oral• single dose

    Dose per protocol (not specified in registry summary). Psychological support provided.

Placebo

inactive

Placebo control with matched psychological support.

Interventions

  • Placebo
    via Oral• single dose

    Matched placebo.

Participants

Ages
25 – 80
Sexes
Male & Female

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Details

Locations

United Kingdom

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