San Francisco, California 94121

  • Bipolar II Disorder

Purpose:

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


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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


NCT ID:

NCT05065294


Primary Contact:

Principal Investigator
Joshua D Woolley, MD,PhD
University of California, San Francisco

Kimberly Sakai
Phone: 415-221-4810 ext. 24074
Email: PsilocybinStudies@ucsf.edu


Backup Contact:

N/A


Location Contact:

San Francisco, California 94121
United States

Kimberly Sakai
Phone: 415-221-4810
Email: psilocybinstudies.@ucsf.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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