Optimi Health to Initiate Phase 2 Clinical Trial Evaluating Psilocybin-Assisted Therapy for Major Depressive Disorder
Optimi Health announced plans to initiate a Health Canada-authorized, multisite Phase 2 trial of psilocybin-assisted therapy for major depressive disorder, enrolling up to 200 participants at sites across Canada. The trial is slated to begin in the first half of 2027, with dosing expected to be complete by the end of 2027. The study will test a single supervised dose of naturally derived psilocybin, with the primary efficacy endpoint being change in MADRS total score from baseline, plus periodic interim safety and efficacy readouts.
Key figures
- Drug Name
- natural psilocybin
- Phase Of Trial
- Phase 2
- Condition
- major depressive disorder (MDD)
- Trial start
- first half of 2027
- Dosing regimen
- single supervised dose
- Interim readouts
- periodic interim safety and efficacy readouts planned
- Primary endpoint
- change in MADRS total score from baseline
- Dosing completion
- end of 2027
- Planned enrollment
- 200
- Regulatory authorization
- Health Canada
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