San Francisco,
California
94121
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