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A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06793397•Cybin IRL Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must meet all the following criteria to be included in the trial:
•Age18 to 85 years.
•Participant has a diagnosis of MDD.
•Moderate to severe depression at Screening.
•Participants have been on a stable dose of antidepressant medication at an adequate dose in the last 4 weeks prior to Screening.
•Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening.
•Participants with well controlled hypertension.
•Participant is able to refrain from smoking during the dosing session.
•Participants must use a condom plus spermicide during the trial and for 12 weeks afterwards.
•Participants of childbearing potential must agree to use a highly effective method of and a negative pregnancy test at Screening and Day -1 prior to dosing.
+2 more criteria

Exclusion Criteria

•Participants with any of the following characteristics/conditions will be excluded from trial participation:
•Current or previously diagnosed schizophrenia spectrum or other psychotic disorders.
•Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).
•Significant suicide risk within 12 months of Screening.
•Current or previous diagnosis of treatment-resistant MDD.
•Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.
•Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer.
•Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \[including dyspepsia or gastroesophageal reflux disease\], hepatic, or renal disorder).
•Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.
•Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.
+8 more criteria

Locations (67)

UAB Psychiatry and Behavioral Neurology

Birmingham, Alabama, United States

Lighthouse Psychiatry

Gilbert, Arizona, United States

Pillar Clinical Research - Little Rock

Little Rock, Arkansas, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Sun Valley Research Center

Imperial, California, United States

CalNeuro Research Group

Los Angeles, California, United States

ATP Clinical Research

Orange, California, United States

NRC Research Institute

Orange, California, United States

Inland Psychiatric Medical Group Inc (IPMG Research)

San Juan Capistrano, California, United States

Psychedelic Science Institute

Santa Monica, California, United States

Key Dates

Start Date

December 10, 2025

Primary Completion Date

March 18, 2027

Completion Date

May 8, 2027

Last Updated

March 19, 2026

Enrollment

330

ESTIMATED participants

Conditions

Major Depressive Disorder (MDD)Depression in AdultsDepression - Major Depressive DisorderDepression DisordersDepression DisorderDepression

Interventions

CYB003

DRUG

Psychological Support

BEHAVIORAL

Contacts

Clinical Development

CONTACT

1-866-292-4601 x799 clinicaltrialsinfo@cybin.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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