Psilocybin-Assisted Therapy for... — Clinical Trial Details

Phase III interventional

Randomized, quadruple Blind

Randomised, quadruple-masked, parallel-group Phase III trial (n=90) assessing single-dose psilocybin 25 mg assisted therapy versus a 1 mg active placebo in adults with treatment-resistant bipolar II depression; primary objective is effectiveness, safety and tolerability over 12 weeks.

Participants have up to 30 days of screening and ~12 weeks of follow-up (11 study visits over ~16 weeks), including five therapy sessions delivered by trained study therapists; key exclusions include history of psychosis, seizures, recent psychedelic use, unstable medical illness, and pregnancy.

Study Protocol

Preparation

sessions

Dosing

1 sessions

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

Inclusion Criteria:
1. Male or female aged 19 to 65 years inclusive.
2. Diagnosis of bipolar disorder type II, currently in a major depressive episode.
3. Willing to use highly effective contraception for study duration OR abstain from heterosexual intercourse; females without childbearing potential must be postmenopausal ≥1 year (FSH confirmed) OR surgically sterile.
4. Sufficient English language skills to consent and comply with study visits and follow-up.
5. Current medications stable dose for two weeks prior to dosing visit.

Exclusion Criteria:
1. History of psychotic symptoms.
2. History of seizures.
3. Current unstable or inadequately treated medical illness, especially cardiovascular illness (except current depression).
4. Started treatment for acute bipolar depressive episode within past 6 weeks.
5. Began structured psychotherapy within past 8 weeks (e.g., CBT, IPT, family-focused therapy, or interpersonal and social rhythm therapy).
6. History of nonresponse or intolerance to psilocybin.
7. Used any psychedelic drugs (including ketamine, LSD, or psilocybin-containing mushrooms) within past 6 months.
8. History of non-response to electroconvulsive therapy.
9. Pregnant or lactating.

Start: 2025-06-01

End: 2028-12-01

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Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder (PAT-BD-01)

Detailed Description

Study Protocol

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Therapeutic Protocol

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Active

Interventions

Placebo

Interventions

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Exclusion Criteria

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