Psilocybin-assisted therapy for treatment-resistant bipolar II depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized, double-blind, parallel-group trial lasting up to 16 weeks (12 weeks of active treatment with up to 30 days screening). It compares single-dose psilocybin-assisted therapy (25 mg) to an active placebo (1 mg) in adults with bipolar II depression who have failed at least two prior treatment regimens. Participants attend multiple study visits and receive psychological support in conjunction with the medication. Safety, tolerability, and short-term efficacy will be assessed under strict screening and monitoring guidelines.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Dr. Lakshmi N Yatham — UBC Department of Psychiatry
• Study coordinator: Vy Ngo, B.Sc
• Email: vy.ngo@ubc.ca
• Phone: 604-822-3769

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.