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Recruiting Phase 3 Interventional

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

ClinicalTrials.gov ID: NCT06793397

Public ClinicalTrials.gov record NCT06793397. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 19, 2026, 9:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

Study identification

NCT ID
NCT06793397
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cybin IRL Limited
Industry
Enrollment
330 participants

Conditions and interventions

Interventions

Drug · Behavioral

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 9, 2025
Primary completion
Mar 17, 2027
Completion
May 7, 2027
Last update posted
Aug 25, 2026

2025 – 2027

United States locations

U.S. sites
34
U.S. states
18
U.S. cities
32
Facility City State ZIP Site status
UAB Psychiatry and Behavioral Neurology Birmingham Alabama 35209 Recruiting
Lighthouse Psychiatry Gilbert Arizona 85234 Recruiting
Pillar Clinical Research - Little Rock Little Rock Arkansas 72204 Withdrawn
Behavioral Research Specialists, LLC Glendale California 91206 Recruiting
Sun Valley Research Center Imperial California 92251 Withdrawn
CalNeuro Research Group Los Angeles California 90025 Recruiting
ATP Clinical Research Orange California 92866 Recruiting
NRC Research Institute Orange California 92868 Recruiting
Inland Psychiatric Medical Group Inc (IPMG Research) San Juan Capistrano California 92675 Not yet recruiting
Psychedelic Science Institute Santa Monica California 90404 Recruiting
Stanford University Stanford California 94305 Withdrawn
Yale School of Medicine - Yale Program for Psychedelic Science New Haven Connecticut 06511 Recruiting
CNS Healthcare Jacksonville Florida 32256 Recruiting
Accel Research Sites - Maitland Maitland Florida 32751 Recruiting
Aqualane Clinical Research Naples Florida 34105 Recruiting
Emory University Dept of Psychiatry and Behavioral Studies Atlanta Georgia 30329 Not yet recruiting
Psych Atlanta Marietta Georgia 30060 Recruiting
Rush University Chicago Illinois 60612 Recruiting
Tandem Clinical Research Marrero Louisiana 70006 Not yet recruiting
Atlas Psychiatry New Orleans Louisiana 70115 Recruiting
Johns Hopkins Medicine Baltimore Maryland 21224 Not yet recruiting
Institute for Integrative Therapies Eden Prairie Minnesota 55347 Recruiting
Redbird Research, LLC Las Vegas Nevada 89119 Recruiting
Bio Behavioral Health Toms River New Jersey 08755 Recruiting
New York State Psychiatric Institute New York New York 10032 Not yet recruiting
SP Research PLLC Oklahoma City Oklahoma 73112 Withdrawn
Adams Clinical Philadelphia Philadelphia Pennsylvania 19104 Recruiting
Flourish Research Philadelphia Philadelphia Pennsylvania 19462 Recruiting
Austin Clinical Trial Partners Austin Texas 78737 Not yet recruiting
North Texas Clinical Trials Fort Worth Texas 76104 Withdrawn
Brain Health Consultants and TMS Center Houston Texas 77046 Recruiting
Flourish Research San Antonio San Antonio Texas 78229 Recruiting
Core Clinical Research Everett Washington 98201 Not yet recruiting
Seattle Neuropsychiatric Treatment Center Seattle Washington 98104 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06793397, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 25, 2026 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06793397 live on ClinicalTrials.gov.

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