Clinical TrialBipolar DisorderPsilocybinActive not recruiting

Psilocybin Therapy for Depression in Bipolar II Disorder (BAP)

The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.

Target Enrollment
14 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, single-arm pilot enrolling 14 adults with Bipolar II disorder and current depression to assess safety, tolerability, and feasibility of psilocybin therapy with preparatory and integration sessions.

Participants receive one or two supervised oral psilocybin sessions (10–25 mg) ~3 weeks apart; primary outcomes are safety and feasibility and efficacy is explored via change in MADRS three weeks after final administration, with additional measures of sleep, quality of life, and therapeutic engagement.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin therapy

experimental

One- or two-dose open-label psilocybin therapy with preparatory and integration sessions.

Interventions

  • Psilocybin10 - 25 mg
    via Oral• one or two sessions• 2 doses total

    10–25 mg oral; second dose optional ~3 weeks after the first; psychological support and clinician safety monitoring.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age 18 to 70
  • Comfortable speaking and writing in English
  • Diagnosis of Bipolar Disorder II with current depression
  • Have a care partner/support person available throughout the study
  • Able to attend all in-person visits at UCSF as well as virtual visits
  • Having tried at least one previous medication trials for their bipolar disorder, each lasting at 6 weeks or more.

Exclusion Criteria

  • Exclusion Criteria:
  • Current or previous diagnosis of Bipolar I Disorder
  • History of schizophrenia spectrum or psychotic disorder
  • Use of psychedelics within the past 6 months, including MDMA
  • Current diagnosis of cancer
  • Seizures that continue to the present
  • Fear of blood or needles
  • Regular use of medications that may have problematic interactions with psilocybin, including but not limited to antidepressants (Bupropion allowed), serotonin antagonists, some antipsychotics, dopamine agonists/antagonists, stimulants, opioids, and Lithium.
  • A health condition that makes this study unsafe or unfeasible, determined by study physicians

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment14 participants
  • Timeline
    Start: 2021-11-11
    End: 2023-09-09
  • Compound
    Psilocybin
  • Topic
    Bipolar Disorder

Locations

University of California, San Francisco — San Francisco, California, United States

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