Psilocybin Therapy for Depression in Bipolar II Disorder

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: N,N-Dimethyltryptamine; Psilocybin

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