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NCT06793397 · ClinicalTrials.gov registry record · Phase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
A Phase 3 study of Depression and Major Depressive Disorder (MDD), sponsored by Cybin IRL Limited.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
- 20
- Study locations
NCT06793397 is a Phase 3 study of Depression and Major Depressive Disorder (MDD) that is actively recruiting participants, run by Cybin IRL Limited. The registered enrollment target is 330 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT06793397, a Phase 3 study of Depression and Major Depressive Disorder (MDD), is actively recruiting participants, sponsored by Cybin IRL Limited.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG CYB003
- BEHAVIORAL Psychological Support
Study Locations (20)
California
- Behavioral Research Specialists, LLC - Glendale
- Sun Valley Research Center - Imperial
- CalNeuro Research Group - Los Angeles
- ATP Clinical Research - Orange
- NRC Research Institute - Orange
- Inland Psychiatric Medical Group Inc (IPMG Research) - San Juan Capistrano
- Psychedelic Science Institute - Santa Monica
- Stanford University - Stanford
Florida
- CNS Healthcare - Jacksonville
- Accel Research Sites - Maitland - Maitland
- Aqualane Clinical Research - Naples
Georgia
- Emory University Dept of Psychiatry and Behavioral Studies - Atlanta
- Psych Atlanta - Marietta
Alabama
- UAB Psychiatry and Behavioral Neurology - Birmingham
Arizona
- Lighthouse Psychiatry - Gilbert
Arkansas
- Pillar Clinical Research - Little Rock - Little Rock
Connecticut
- Yale School of Medicine - Yale Program for Psychedelic Science - New Haven
Illinois
- Rush University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2025-12-10 |
| Est. Completion | 2027-05-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06793397
The ClinicalTrials.gov registry entry for NCT06793397 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (58% lower). The listed sponsor is Cybin IRL Limited, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which CYB003 is the first listed.
NCT06793397 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT06793397 about?
NCT06793397 is a clinical study titled "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder". 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.
What is the current status of trial NCT06793397?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2025-12-10. Estimated completion is 2027-05-08.
What conditions does trial NCT06793397 study?
This clinical trial studies the following conditions: Depression, Major Depressive Disorder (MDD), Depression - Major Depressive Disorder, Depression Disorders, Depression in Adults.
What interventions are being tested in trial NCT06793397?
The interventions under investigation include: CYB003 (DRUG), Psychological Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT06793397?
This trial is sponsored by Cybin IRL Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06793397 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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