Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder
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…
Conditions studied
Bipolar II Depression
About this study
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.
Interventions
- Drug: psilocybin (25 mg) — Single-dose psilocybin (25 mg)-assisted therapy (PAT)
- Drug: psilocybin 1mg micro-dose — Single dose active placebo psilocybin-assisted therapy
Primary outcomes
- Change in depressive symptoms (Baseline to Week 3)
Eligibility information
Study locations
- Djavad Mowafaghian Centre for Brain Health, Vancouver, British Columbia V6T 1Z3 Canada
- Department of Psychiatry, University of Ottawa, The Ottawa Hospital, Ottawa, Ontario K1H 8L6 Canada
- Department of Psychiatry, University of Toronto, University Health Network,, Toronto, Ontario M5T 2S8 Canada
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.