Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing psilocybin (25 mg) for Bipolar II Depression

This study is a 12-week (in addition to up to 30 days of screening) randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, 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 dummy treatment (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.

Official registry: https://clinicaltrials.gov/study/NCT06943573 · Lakshmi N Yatham · enrollment listed as 90

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are psilocybin (25 mg), or psilocybin 1mg micro-dose. The registry lists allocation as randomized. This study is a 12-week (in addition to up to 30 days of screening) randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial.

They plan to enroll about 90 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder: A Randomized Controlled Trial

Interventions: psilocybin (25 mg), psilocybin 1mg micro-dose

Primary outcome (registry wording): Change in depressive symptoms

Who it is for (from inclusion criteria)

  • Ages 19 Years to 65 Years
  • You are male or female aged 19 to 65 years inclusive
  • You have a diagnosis of bipolar disorder type II, and are currently in a major depressive episode
  • You have sufficient English language skills to understand, consent to, and comply with study requirements, study visits, and to return to the clinic for follow-up evaluations
  • Your current medications have been at a stable dose for two weeks prior to the dosing visit

Public study contact (from the registry)

Vy Ngo, B.Sc

604-822-3769

vy.ngo@ubc.ca

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

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FAQ about this NCT record

Is NCT06943573 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06943573?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06943573?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary