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... (The sponsor's summary, shortened.)
Eligibility and contacts on ClinicalTrials.govThe registry record
- Status
- Recruiting
- Phase
- Phase 2
- Conditions
- Bipolar II Depression
- Intervention
- psilocybin (25 mg); psilocybin 1mg micro-dose
- Sponsor
- Lakshmi N Yatham
- Ages
- 19 Years to 65 Years
- Sex
- All
- Healthy volunteers
- No
- Enrolment
- 90 people (planned)
- Start
- 15 June 2026
- Primary completion
- December 2028
- Registry last updated
- 15 September 2026
Sites (3)
- Djavad Mowafaghian Centre for Brain Health, Vancouver, British Columbia, Canada (recruiting)
- Department of Psychiatry, University of Ottawa, The Ottawa Hospital, Ottawa, Ontario, Canada (not yet recruiting)
- Department of Psychiatry, University of Toronto, University Health Network,, Toronto, Ontario, Canada (not yet recruiting)
How joining a trial works
- Free to take part
- Trials generally cost participants nothing for the study drug and the study visits, and some pay for travel or time. Check what a study covers on its registry page.
- Screened first
- Every study screens volunteers with questionnaires, medical history and often a physical and psychiatric check. Many people who apply are not enrolled.
- Eligibility is strict
- Common exclusions include a personal or family history of psychosis or bipolar disorder, some heart conditions, pregnancy and certain medications, which you may be asked to stop under medical supervision. Never stop a medication on your own to qualify.
- You may get a placebo
- Many trials compare psilocybin with a placebo or a low dose, and you may not be told which you had until the study ends.
- Contact the study team through the registry
- Each registry record lists the study contacts and sites. We do not republish personal emails or phone numbers; use the link on each trial page.
- Not medical advice
- This is a list of registry records, not a recommendation. Talk to your doctor before applying. Disclaimer · Safety and medications
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine, read 28 October 2026. Filter: overall status RECRUITING or NOT_YET_RECRUITING; an intervention named psilocybin, psilocin, COMP360 or CYB003. Refreshed weekly; a study's own registry page is always the current record.
Record read from ClinicalTrials.gov API v2, U.S. National Library of Medicine on 28 October 2026. All psilocybin trials