Trials / Recruiting
RecruitingNCT06793397
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- Sponsor
- Cybin IRL Limited · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.
Conditions
- Major Depressive Disorder (MDD)
- Depression in Adults
- Depression - Major Depressive Disorder
- Depression Disorders
- Depression Disorder
- Depression
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CYB003 | CYB003 is a deuterated psilocin analog. |
| BEHAVIORAL | Psychological Support | Manualized psychological support performed by facilitator. |
Timeline
- Start date
- 2025-12-10
- Primary completion
- 2027-03-18
- Completion
- 2027-05-08
- First posted
- 2025-01-27
- Last updated
- 2026-04-13
Locations
67 sites across 8 countries: United States, Australia, Czechia, Germany, Greece, Ireland, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06793397. Inclusion in this directory is not an endorsement.