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

NCT ID
NCT06943573
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 2
Sponsor
Lakshmi N Yatham

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 90 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 first-degree relative, such as your parent, sibling, or child, with a diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder, schizophrenia). 4. You have a current unstable or inadequately treated medical illness, especially cardiovascular illness, except for the current depression. 5. You recently (i.e., within the past 6 weeks) started taking treatment for your acute bipolar depressive episode. 6. 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). 7. You have a history of nonresponse or intolerance to psilocybin. 8. You have, in the past 6 months, used any psychedelic drugs, including ketamine, LSD, or psilocybin-containing mushrooms. 9. You have a history of non-response to electroconvulsive therapy. 10. You are pregnant or lactating.

Study locations

3 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Canada

  • British Columbia, Canada: 1
  • Ontario, Canada: 2

Sample of listed locations

  • Djavad Mowafaghian Centre for Brain Health — Vancouver, British Columbia, V6T 1Z3, Canada — Site recruitment status not specified in the registry data
  • Department of Psychiatry, University of Ottawa, The Ottawa Hospital — Ottawa, Ontario, K1H 8L6, Canada — Site recruitment status not specified in the registry data
  • Department of Psychiatry, University of Toronto, University Health Network, — Toronto, Ontario, M5T 2S8, Canada — Site recruitment status not specified in the registry data

Study details

Start date
June 15, 2026
Primary completion date
December 1, 2028
First posted
April 24, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06943573
Registry last updated
September 15, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT06943573 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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