Psilocybin Therapy for Depression in Bipolar II Disorder (BAP)

University of California San Francisco (UCSF)

Status and phase: Active, not recruiting; Phase 2

Conditions: Bipolar II Disorder

Treatments: Drug: Psilocybin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05065294

20-32789

Details and patient eligibility

About

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

Full description

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Psilocybin therapy

Experimental group

Description:

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:

Drug: Psilocybin therapy