NCT05065294Active, not recruitingPhase 2
Psilocybin Therapy for Depression in Bipolar II Disorder
An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 14 Sept 2021
- Start date
- 28 Jan 2022
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- University of California, San Francisco
- Diseases
- Bipolar disorder
- NCT number
- NCT05065294
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 14
- From 28 Jan 2022 to the primary completion date, 1 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous diagnosis of Bipolar I Disorder
- 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.
Other illness
- History of schizophrenia spectrum or psychotic disorder
- Current diagnosis of cancer
- Seizures that continue to the present
- A health condition that makes this study unsafe or unfeasible, determined by study physicians
Other
- Use of psychedelics within the past 6 months, including MDMA
- Fear of blood or needles
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.