Summary

Eligibility
for people ages 30-65 (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Joshua D Woolley, MD,PhD (ucsf)
Photo of Joshua D Woolley
Joshua D Woolley

Description

Summary

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

Details

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 30 to 65 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.

Keywords

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

Eligibility

You can join if…

Open to people ages 30-65

  • Age 30 to 65
  • 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 two previous medication trials for their bipolar disorder, each lasting at 6 weeks or more.
  • Have an established mental health care provider who is seen at least twice a month

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 12 months, including MDMA and Ketamine
  • 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

Location

  • University of California, San Francisco
    San Francisco California 94121 United States

Lead Scientist at University of California Health

  • Joshua D Woolley, MD,PhD (ucsf)
    Associate Professor, Psychiatry. Authored (or co-authored) 58 research publications. Research interests: Psychedelics · Pharmacology · Mood and Anxiety Spectrum Disorders · Oxytocin · Schizophrenia Spectrum Disorders · Psilocybin · Clinical Trials.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05065294
Phase
Phase 2
Study Type
Interventional
Last Updated