Clinical TrialParallelTreatment-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).

Ask Blossom about this trial
Target Enrollment
60 participants
Study Type
interventional
Design
Randomized, double Blind

Continue exploring

Continue exploring this trial

Move from the registry record to the most relevant public research context.

Related paper: Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trialCompound research: PsilocybinTopic research: Treatment-Resistant Depression (TRD)

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 (matched to psilocybin 25 mg)

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 Protocol, Arms & Participants

Go Pro to access detailed study protocol timelines, treatment arms, dosing schedules, and participant eligibility criteria.

See Pro Plans

Study Details

Study Team

Sponsors & Collaborators

Investigators

  • JR
    James Rucker

Locations

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

Related Publications

Open AccessindividualMethods

Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial

This protocol paper describes the PsiDeR study, a single-centre, randomised, placebo-controlled feasibility trial of psilocybin-assisted therapy in up to 60 people with treatment‑resistant depression (TRDD), testing a single 25 mg psilocybin dose plus psychological support with primary feasibility outcomes at a 3‑week primary endpoint and 6‑week follow‑up. The protocol also collects optional neuroimaging and omics data for mechanism and biomarker analyses and offers an open‑label 25 mg psilocybin extension.

Published
Journal
BMJ Open
Authors
Rucker, J., Jafari, H., Mantingh, T., Bird, C., Modlin, N. L., Knight, G., Reinholdt, F., Day, C., Carter, B., Young, A.
Open AccessindividualPrimary

Psilocybin-assisted therapy for treatment-resistant major depressive disorder in a public healthcare setting: a randomized controlled trial

This double-blind, randomised, placebo-controlled feasibility trial (n=60) tested a single 25 mg dose of psilocybin with psychological support for people with treatment-resistant major depression in an NHS setting. Psilocybin reduced depressive symptoms more than placebo at three weeks, with benefits sustained at six weeks, although non-serious adverse events were more frequent with psilocybin.

Published
Journal
Nature Medicine
Authors
Rucker, J. J., Mantingh, T., Kerr-Gaffney, J., Bird, C., Chu, P., Modlin, N. L., Campbell-Coker, K., Hambleton, S., Seath, P., Hignett, R., Fennema, D., Hampsey, E., Tsapekos, D., Thomas, R. J., Cattell, J., Jafari, H., Day, C., Borissova, A., Lloyd, M., Boardman-Pretty, T., Seynaeve, M., Askari, F., Creed, M., Baxter, L., Rifkin-Zybutz, R., Butler, M., Jelen, L. A., Carter, B., Young, A. H.

Recent activity

Your Personal Research Library

Go Pro to save trials, add notes, rate research, and organize custom shelves.

See Pro Plans