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Psychedelic
Psilocybin Therapy for Depression in Bipolar II 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
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 moreSecondary 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 moreAwards & 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
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,936 Total Patients Enrolled
1 Trials studying Bipolar Disorder
59 Patients Enrolled for Bipolar Disorder
Joshua D Woolley, MD,PhDPrincipal InvestigatorUniversity of California, San Francisco
David Guard, PhDStudy DirectorSan Francisco State University