Psilocybin-Assisted Therapy for Depression
(PAT-BD-01 Trial)
Trial Summary
Will I have to stop taking my current medications?
You may need to stop taking certain medications at least 2 weeks before the dosing visit and throughout the study, but lamotrigine, valproate, lithium, and lorazepam (up to 2 mg/day) are allowed. The protocol does not specify all prohibited medications, so it's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug psilocybin for depression?
Is psilocybin-assisted therapy generally safe for humans?
Psilocybin-assisted therapy is generally considered safe when administered under supervision, with most side effects being mild and temporary. Serious adverse events are uncommon, but there have been reports of increased suicidal thoughts and behaviors in some cases, so further research is needed to understand who might be at risk.678910
How is the drug psilocybin different from other depression treatments?
Psilocybin is unique because it can produce rapid and lasting antidepressant effects with just one or two doses, unlike traditional antidepressants that often require daily use. It works by activating serotonin 2A receptors in the brain, which is different from how most standard depression medications function.1361112
What is the purpose of this trial?
This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e. quetiapine, lithium, lamotrigine, sertraline, or venlafaxine as monotherapy or adjunctive therapy, or bupropion adjunctive therapy). The active placebo is a substance that looks identical to the study medication but contains less therapeutic ingredients, and thus is less capable of producing the transformative and meaningful aspects of psychedelic experience compared to the 25 mg dose. Participants will have a total of 11 study visits over a period of up to 16 weeks, which includes 5 therapy sessions from trained study therapists.
Research Team
Dr. Lakshmi N Yatham
Principal Investigator
UBC Department of Psychiatry
Eligibility Criteria
This trial is for individuals with bipolar II depression who haven't improved after trying at least two different treatments, such as quetiapine, lithium, or sertraline. Participants should be stable and have no other psychological conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of psilocybin (25 mg) or active placebo (1 mg) with therapy sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lakshmi N Yatham
Lead Sponsor