Clinical trial NCT05065294: Psilocybin Therapy for Depression in 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Bipolar II Disorder
Keywords: Bipolar
Depression
Psilocybin
Psychedelic
Psilocybin Therapy
Bipolar II
Safety
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, single-arm, pilot study
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability of psilocybin therapy for depression in BD II
timeFrame: Baseline to 3 months following last drug dose
measure: Recruitment rate
timeFrame: Baseline to 3 months following last drug dose
measure: Retention rate
timeFrame: Baseline to 3 months following last drug dose
measure: Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II
timeFrame: Baseline to 3 weeks following last drug dose
measure: Treatment Satisfaction of study procedures
timeFrame: Baseline to 3 months following last drug dose
measure: Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II
timeFrame: Baseline to 11 days following each drug dose
measure: Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II
timeFrame: Baseline to 3 months following each drug dose
measure: Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II
timeFrame: Baseline to 3 months following last drug dose
Secondary outcomes:
measure: Patient reported effects of psilocybin therapy on depressive symptoms symptoms in people with Bipolar II (exploratory)
timeFrame: Baseline to 3 months following last drug dose
measure: Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory)
timeFrame: Baseline to 3 months following last drug dose
measure: Effects of psilocybin therapy on sleep quality in people with Bipolar II (exploratory)
timeFrame: Baseline to 3 months following last drug dose
measure: Effects of psilocybin therapy on quality of life in people with Bipolar II (exploratory)
timeFrame: Baseline to 3 months following last drug dose
measure: Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory)
timeFrame: Baseline to 3 months following last drug dose
measure: Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory)
timeFrame: Baseline to 3 months following last drug dose
measure: Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory)
timeFrame: Baseline to 3 months following last drug dose
measure: Subjective effects of psilocybin therapy in people with Bipolar II
timeFrame: Baseline to 3 months following last drug dose
measure: Subjective effects of psilocybin therapy in people with Bipolar II
timeFrame: 3 weeks following last drug dose
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joshua D Woolley, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Francisco State University
name: David Guard, PhD
role: STUDY_DIRECTOR
References:
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