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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 Oct 19, 2026, 5:09 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 17, 2024 (Actual)
Primary completion
Sep 4, 2026 (Actual)
Completion
Oct 2026 (Estimated)
Last update posted
Sep 28, 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 DeSoto 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 Sep 28, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06564818 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →