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NCT06564818 · 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 Major Depressive Disorder, sponsored by Cybin IRL Limited.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT06564818: Recruiting Phase 3 study of Major Depressive Disorder, sponsored by Cybin IRL Limited.
NCT06564818 is a Phase 3 study of Major Depressive Disorder that is actively recruiting participants, run by Cybin IRL Limited. The registered enrollment target is 220 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06564818, a Phase 3 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Cybin IRL Limited.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CYB003
- BEHAVIORAL Psychological Support
Study Locations (20)
California
- CenExel CIT (Clinical Innovations, Inc) - Bellflower
- Kadima Neuropsychiatry Institute - La Jolla
- Bespoke Treatment/Lipov Medical Group - Los Angeles
- Catalina Research Institute - Montclair
- Excell Research, Inc - Oceanside
- Open Mind Therapeutics - San Francisco
- Inland Psychiatric Medical Group Inc - San Juan Capistrano
Florida
- Research Centers of America - Hollywood
- K2 Medical Research-Maitland - Maitland
- Floridian Neuroscience Institute - Miami
- Innovative Clinical Research, INC - North Miami
- Clinical Neuroscience Solutions, Inc - Orlando
- Charter Research - Orlando
- Combined Research Orlando Phase I-IV - Orlando
Arizona
- Scottsdale Research Institute - Phoenix
- Mountain Clinical Trials - Phoenix
- Noble Clinical Research - Tucson
- Del Sol Research Management - Tucson
Colorado
- Mountain View Clinical Research - Denver
- Starlight Clinical Research - Evergreen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-12-17 |
| Est. Completion | 2026-09 |
| Phase | Phase 3 |
What NCT06564818 shows while recruiting
NCT06564818 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06564818 names 20 study sites across 4 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06564818 about?
NCT06564818 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 examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
What is the current status of trial NCT06564818?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2024-12-17. Estimated completion is 2026-09.
What conditions does trial NCT06564818 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06564818?
The interventions under investigation include: Placebo (DRUG), CYB003 (DRUG), Psychological Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT06564818?
This trial is sponsored by Cybin IRL Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06564818 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06564818's enrollment target sits among peer trials
220 69th of 282 higher than 213 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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