for people ages 18-70 (full criteria)
at San Francisco, California
study started
completion around
Principal Investigator
by Joshua D Woolley, MD,PhD
Headshot of Joshua D Woolley
Joshua D Woolley



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

Official Title

An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder


The primary goal of this study is to examine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder (BD II). Fourteen participants, ages 18 to 70 with clinically diagnosed BD II with active depression, in active outpatient mental health treatment, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by an initial drug administration of oral psilocybin,supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will complete assessment and integration sessions with the facilitators subsequently in order to help process the experience. Participants who tolerated the first dosage may be asked to complete a second psilocybin dosing session, involving the same preparation, procedures, integration, and supervision as the first. Primary outcome measures will assess safety, tolerability, and feasibility of study procedures. Efficacy will be measured by change in depression as measured by the MADRS three weeks after the final psilocybin administration. Exploratory outcome measures will assess changes in sleep, quality of life, and therapeutic engagement.


Bipolar II Disorder, Bipolar, Depression, Psilocybin, Psychedelic, Psilocybin Therapy, Bipolar II, Safety, N,N-Dimethyltryptamine


You can join if…

Open to people ages 18-70

  • 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.

You CAN'T join if...

  • 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


  • UCSF
    San Francisco California 94121 United States

Lead Scientist at UCSF

  • Joshua D Woolley, MD,PhD
    Dr. Josh Woolley is an Associate Professor in Residence in the Department of Psychiatry and Behavioral Sciences at the University of California, San Francisco (UCSF) as well as a staff psychiatrist in Mental Health at the San Francisco Veterans Affairs Medical Center (SFVAMC). He is Board Certified in Psychiatry by the American Board of Psychiatry and Neurology.


in progress, not accepting new patients
Start Date
Completion Date
University of California, San Francisco
Phase 2 research study
Study Type
Expecting 14 study participants
Last Updated