Clinical TrialBipolar DisorderPsilocybinPsilocybinNot yet recruiting

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

This randomised, quadruple-blind, placebo-controlled Phase III trial (n=90) will study the effectiveness, safety, and tolerability of psilocybin (25 mg)–assisted therapy compared to an active placebo (1 mg psilocybin) in individuals with treatment-resistant depression associated with bipolar II disorder.

Target Enrollment
90 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

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

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Active

experimental

Single therapeutic dose psilocybin (25 mg) assisted therapy.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Single-dose psilocybin-assisted therapy (therapeutic dose)

Placebo

active

Active placebo: 1 mg psilocybin micro-dose.

Interventions

  • Psilocybin1 mg
    via Oral• single dose• 1 doses total

    Active placebo (micro-dose)

Participants

Ages
19 – 65
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment90 participants
  • Timeline
    Start: 2025-06-01
    End: 2028-12-01
  • Compounds
    PsilocybinPsilocybin
  • Topic
    Bipolar Disorder

Locations

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

Your Library