Psilocybin therapy for Bipolar Disorder (BAP Trial)

Phase 2

Waitlist Available

Led By Joshua D Woolley, MD,PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months following last drug dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and feasibility of using psilocybin, a substance from 'magic mushrooms,' to help people with Bipolar II Disorder who are currently depressed. Researchers want to see if this treatment can safely improve mood and quality of life for these patients. Psilocybin has shown promise as a treatment for depression and has been designated as a breakthrough therapy by the FDA.

Eligible Conditions

Bipolar Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months following last drug dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 months following last drug dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months following last drug dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II

Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II

Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II

+5 more

Secondary study objectives

Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory)

Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory)

Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Psilocybin therapyExperimental Treatment1 Intervention

Participants will receive one or two doses of psilocybin in a monitored setting approximately three weeks apart, with preparation sessions before and integration sessions after.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin therapy

2021

Completed Phase 2

~20

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