Psilocybin for Bipolar Disorder
Trial Summary
What is the purpose of this trial?
The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression.
Research Team
Thomas Meyer, PhD
Principal Investigator
The University of Texas Health Science Center, Houston
Eligibility Criteria
This trial is for individuals with Bipolar Disorder II who are experiencing depression and may have suicidal thoughts. Participants must be stable on their current medications and in good physical health to handle the psilocybin treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to two sequential doses of 25 mg psilocybin with therapeutic support
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- Treatment-resistant depression (TRD) under PRIME designation
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Anne and Don Fizer Foundation
Collaborator