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Not yet recruitingPhase 3

Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder

NCT06943573 · PAT-BD-01 · Lakshmi N Yatham

Closed to entry
Status
Not accepting participants
Phase 3
Phase
90
Target enrolment
3
Study sites
Outside the US

What it is testing

Summary

This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e. quetiapine, lithium, lamotrigine, sertraline, or venlafaxine as monotherapy or adjunctive therapy, or bupropion adjunctive therapy). The active placebo is a substance that looks identical to the study medication but contains less therapeutic ingredients, and thus is less capable of producing the transformative and meaningful aspects of psychedelic experience compared to the 25 mg dose. Participants will have a total of 11 study visits over a period of up to 16 weeks, which includes 5 therapy sessions from trained study therapists.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in depressive symptoms

    Measured over Baseline to Week 3

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

19 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. You are male or female aged 19 to 65 years inclusive. 2. You have a diagnosis of bipolar disorder type II, and are currently in a major depressive episode. 3. You are willing, for the entire duration of the study, to practice highly effective methods of contraception (e.g., contraceptive pills, intrauterine device or system, vasectomy and tubal ligation, or double-barrier methods of contraception) OR agree to completely abstain from heterosexual intercourse. Females who do not have childbearing potential are required to be postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) OR surgically sterile. 4. You have sufficient English language skills to understand, consent to, and comply with study requirements, study visits, and to return to the clinic for follow-up evaluations. 5. Your current medications have been at a stable dose for two weeks prior to the dosing visit. Exclusion Criteria: 1. You have a history of psychotic symptoms. 2. You have a history of seizures. 3. You have a current unstable or inadequately treated medical illness, especially cardiovascular illness, except for the current depression. 4. You recently (i.e., within the past 6 weeks) started taking treatment for your acute bipolar depressive episode. 5. You recently (i.e., within the past 8 weeks) began structured psychotherapy (e.g., cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy). 6. You have a history of nonresponse or intolerance to psilocybin. 7. You have, in the past 6 months, used any psychedelic drugs, including ketamine, LSD, or psilocybin-containing mushrooms. 8. You have a history of non-response to electroconvulsive therapy. 9. You are pregnant or lactating.

Where

3 study sites

FacilityCityRegionCountry
Djavad Mowafaghian Centre for Brain HealthVancouverBritish ColumbiaCanada
Department of Psychiatry, University of Ottawa, The Ottawa HospitalOttawaOntarioCanada
Department of Psychiatry, University of Toronto, University Health Network,TorontoOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06943573 on ClinicalTrials.gov →

Last updated in the registry 2026-05-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance