Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinPlaceboUnknown status

A randomised, placebo controlled trial of psilocybin in treatment resistant depression: A feasibility study

This randomised, placebo-controlled trial (n=60) investigates the feasibility of using a single dose of psilocybin (25mg) as a treatment for adults with treatment-resistant major depressive disorder (TRD).

Target Enrollment
60 participants
Study Type
interventional
Design
Randomized

Detailed Description

Randomised, placebo-controlled feasibility study in adults (25–80 years) with treatment-resistant depression testing a single 25 mg oral dose of psilocybin with psychological support.

Primary aim is feasibility; outcomes include safety, tolerability, and depressive symptom change following a single dosing session with preparatory and integration therapy.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single oral dose psilocybin (25 mg) with psychological support.

Interventions

  • Psilocybin25 mg
    via Oral• single dose

Placebo

inactive

Placebo control with identical psychological support.

Interventions

  • Placebo
    via Oral• single dose

    Placebo capsule matched to psilocybin

Participants

Ages
25 – 80
Sexes
Male & Female

Inclusion Criteria

No inclusion criteria listed.

Exclusion Criteria

No exclusion criteria listed.

Study Details

Locations

Clinical Research Facility, King's College Hospital — London, United Kingdom

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