Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Depression and Major Depressive Disorder (MDD), sponsored by Cybin IRL Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phased questions about symptoms to more detailed ones allowing a precise rating of severity. The total score ranges 0-60, higher scores denote greater severity.
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 |
What NCT06793397 shows while recruiting
NCT06793397 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (58% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Depression
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 NCT06793397's enrollment target sits among peer trials
330 128th of 679 higher than 552 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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
-
Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
RECRUITING · Phase 3
-
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
RECRUITING · Phase 3
-
PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study
RECRUITING · Phase 3
-
Creatine for Depressed Male and Female Methamphetamine Users
RECRUITING · Phase 3
-
E-Mindfulness Approaches for Living After Breast Cancer
RECRUITING · Phase 3
-
Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00359684 · 330 participants
Use of Cysteamine in the Treatment of Cystinosis
- NCT03817502 · 330 participants · Phase 3
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
- NCT03922724 · 330 participants · Phase 2
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
- NCT03932773 · 330 participants · NA
Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy