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Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder

NCT06943573 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-01

No results posted yet for this study

Summary

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.

Conditions

  • Bipolar II Depression

Interventions

DRUG

psilocybin (25 mg)

Single-dose psilocybin (25 mg)-assisted therapy (PAT)

DRUG

psilocybin 1mg micro-dose

Single dose active placebo psilocybin-assisted therapy

Sponsors & Collaborators

  • Lakshmi N Yatham

    lead OTHER

Principal Investigators

  • Dr. Lakshmi N Yatham · UBC Department of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06943573 on ClinicalTrials.gov