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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06564818

Public ClinicalTrials.gov record NCT06564818. 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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 9:29 AM EDT

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

Official title

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

Brief summary

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

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.

Study identification

NCT ID
NCT06564818
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cybin IRL Limited
Industry
Enrollment
220 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 16, 2024
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026
Last update posted
Aug 11, 2026

2024 – 2026

United States locations

U.S. sites
45
U.S. states
18
U.S. cities
38
Facility City State ZIP Site status
Scottsdale Research Institute Phoenix Arizona 85022
Mountain Clinical Trials Phoenix Arizona 85050
Noble Clinical Research Tucson Arizona 85704
Del Sol Research Management Tucson Arizona 85715
CenExel CIT (Clinical Innovations, Inc) Bellflower California 90706
Kadima Neuropsychiatry Institute La Jolla California 92037
Bespoke Treatment/Lipov Medical Group Los Angeles California 90025
Catalina Research Institute Montclair California 91763
Excell Research, Inc Oceanside California 92056
Open Mind Therapeutics San Francisco California 94114
Inland Psychiatric Medical Group Inc San Juan Capistrano California 92675
Mountain View Clinical Research Denver Colorado 80209
Starlight Clinical Research Evergreen Colorado 80439
Research Centers of America Hollywood Florida 33024
K2 Medical Research-Maitland Maitland Florida 32751
Floridian Neuroscience Institute Miami Florida 33135
Segal Trials West Broward North Miami Florida 33161
Clinical Neuroscience Solutions, Inc Orlando Florida 32801
Charter Research Orlando Florida 32803
Combined Research Orlando Phase I-IV Orlando Florida 32807
K2 Medical Research - Tampa Tampa Florida 33634
Atlanta Center for Medical Research, CenExel Atlanta Georgia 30331
CenExel iResearch Atlanta Decatur Georgia 30330
CenExel iResearch Savannah Savannah Georgia 31405
Great Lakes Clinical Trials, DBA Flourish Research Chicago Illinois 60640
Uptown Research Institute Chicago Illinois 60640
Psychiatric Medicine Associates, LLC Skokie Illinois 60076
DelRicht Research New Orleans Louisiana 70115
Sunstone Medical, PC Rockville Maryland 20850
Adams Clinical Boston Boston Massachusetts 02116
Adams Clinical Boston Massachusetts 02472
Elixia Health Springfield Massachusetts 01103
Redbird Research, LLC Las Vegas Nevada 89119
Oasis Clinical Trials Las Vegas Nevada 89121
Global Medical Institutes, Princeton Medical Institute Princeton New Jersey 08540
Adams Clinical Harlem New York New York 100029
Adams Clinical Bronx The Bronx New York 10461
Monroe Biomedical Research Monroe North Carolina 28112
Neurobehavioral Clinical Research North Canton Ohio 44720
Adams Clinical Philadelphia Philadelphia Pennsylvania 19104
Clinical Neuroscience Solutions, CNS Healthcare Memphis Tennessee 38119
InSite Clinical Research, LLC DeSota Texas 75115
Zillan Clinical Research Houston Texas 77433
Cedar Clinical Research Murray Utah 84107
Inner Space Research, LLC Orem Utah 84058

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06564818, 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 11, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06564818 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →