Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06943573
PHASE3

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

Sponsor: Lakshmi N Yatham

View on ClinicalTrials.gov

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.

Official title: Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

19 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-10

Completion Date

2028-12

Last Updated

2025-08-27

Healthy Volunteers

No

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

Locations (3)

Djavad Mowafaghian Centre for Brain Health

Vancouver, British Columbia, Canada

Department of Psychiatry, University of Ottawa, The Ottawa Hospital

Ottawa, Ontario, Canada

Department of Psychiatry, University of Toronto, University Health Network,

Toronto, Ontario, Canada