Trials / Recruiting
RecruitingNCT06564818
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (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 examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CYB003 | CYB003 is a Deuterated Psilocin Analog. |
| BEHAVIORAL | Psychological Support | Manualized psychological support performed by facilitators |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2024-12-17
- Primary completion
- 2026-08-01
- Completion
- 2026-09-01
- First posted
- 2024-08-21
- Last updated
- 2026-04-15
Locations
47 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06564818. Inclusion in this directory is not an endorsement.