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

NCT06564818 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CYB003-002
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 46

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; Psilocybin; Psychedelic; Psilocin; CYB003; CYB003-001; Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity.

  Screening Day-45, Baseline Day-1, Day 2, Day 10, Day 21, Day 23, Day 31, and Day 42 (End of Treatment)

Secondary Outcomes (4)

• The Beck Depression Inventory-Second Edition (BDI-II)

  Baseline Day-1, Day 21, and Day 42 (End of Treatment)

• The Clinical Global Impression Scale (CGI-S)

  Screening Day-45, Baseline Day-1, and Day 42 (End of Treatment)

• The Generalized Anxiety Disorder 7-item scale (GAD-7)

  Baseline Day-1, Day 21, and Day 42 (End of Treatment)

• The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

  Baseline Day-1, Day 21, and Day 42 (End of Treatment)

Study Arms (2)

Experimental Arm A: CYB003 in 2 of 2 Dosing Sessions

EXPERIMENTAL

Arm A participants will receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm A participants will continue on their current antidepressants and receive psychological support throughout the study.

Drug: CYB003; Behavioral: Psychological Support

Placebo Comparator Arm B: Placebo in 2 of 2 Dosing Sessions

PLACEBO COMPARATOR

Arm B participants will receive placebo in 2 of 2 Dosing Sessions, approximately three weeks apart. All Arm B participants will continue on their current antidepressants and receive psychological support throughout the study. Non-responders will be eligible to receive CYB003 in a subsequent extension trial.

Behavioral: Psychological Support; Drug: Placebo

Interventions

Psychological Support BEHAVIORAL

Manualized psychological support performed by facilitators

Experimental Arm A: CYB003 in 2 of 2 Dosing Sessions; Placebo Comparator Arm B: Placebo in 2 of 2 Dosing Sessions

CYB003 DRUG

CYB003 is a Deuterated Psilocin Analog.

Experimental Arm A: CYB003 in 2 of 2 Dosing Sessions

Placebo DRUG

Placebo

Placebo Comparator Arm B: Placebo in 2 of 2 Dosing Sessions

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria to be included in the trial:
• Aged 18 to 85 years inclusive, at Screening
• Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \[if single episode, duration of ≥4 weeks and ≤24 months\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.
• Depression is of moderate to severe degree at Screening and Baseline, independently confirmed by additional clinical assessments
• Participant has been on a stable dose of a single antidepressant medication at an adequate dose (label specified) for an adequate duration in the last month prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.
• Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤ 40 kg/m2), inclusive, at Screening.
• Participant is able to refrain from nicotine use during the dosing session (up to 8 hours)
• Registered with a healthcare professional who can confirm the diagnosis and previous treatments received by the participant.
• Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.
• Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.
• Participant has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.

You may not qualify if:

• Participants with any of the following characteristics/conditions will be excluded from trial participation:
• Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder.
• Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD
• Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first degree relatives).
• Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within 12 months of Screening.
• Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview.
• 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 antidepressant, mirtazapine, trazodone, moclobemide, buspirone, ketamine or S-ketamine, or an antipsychotic or mood stabilizer for MDD. Note: if receiving these medications for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1.
• Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening.
• Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.
• Clinically relevant history of abnormal physical health interfering with the trial as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \[including dyspepsia or gastroesophageal reflux disease\], hepatic, or renal disorder).
• Participants with renal insufficiency.
• 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 or blood pressure
• History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the trial medication.

Sponsors & Collaborators

• Cybin IRL Limited: lead

Study Sites (46)

Scottsdale Research Institute

Phoenix, Arizona, 85022, United States

RECRUITING

Mountain Clinical Trials

Phoenix, Arizona, 85050, United States

RECRUITING

Noble Clinical Research

Tucson, Arizona, 85704, United States

RECRUITING

Del Sol Research Management

Tucson, Arizona, 85715, United States

RECRUITING

CenExel CIT (Clinical Innovations, Inc)

Bellflower, California, 90706, United States

RECRUITING

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

RECRUITING

Bespoke Treatment/Lipov Medical Group

Los Angeles, California, 90025, United States

RECRUITING

Catalina Research Institute

Montclair, California, 91763, United States

RECRUITING

Excell Research, Inc

Oceanside, California, 92056, United States

RECRUITING

Open Mind Therapeutics

San Francisco, California, 94114, United States

RECRUITING

Inland Psychiatric Medical Group Inc

San Juan Capistrano, California, 92675, United States

RECRUITING

Mountain View Clinical Research

Denver, Colorado, 80209, United States

RECRUITING

Starlight Clinical Research

Evergreen, Colorado, 80439, United States

RECRUITING

Research Centers of America

Hollywood, Florida, 33024, United States

RECRUITING

K2 Medical Research-Maitland

Maitland, Florida, 32751, United States

RECRUITING

Floridian Neuroscience Institute

Miami, Florida, 33135, United States

RECRUITING

Segal Trials West Broward

North Miami, Florida, 33161, United States

RECRUITING

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

RECRUITING

Charter Research

Orlando, Florida, 32803, United States

RECRUITING

Combined Research Orlando Phase I-IV

Orlando, Florida, 32807, United States

RECRUITING

K2 Medical Research - Tampa

Tampa, Florida, 33634, United States

RECRUITING

Atlanta Center for Medical Research, CenExel

Atlanta, Georgia, 30331, United States

RECRUITING

CenExel iResearch Atlanta

Decatur, Georgia, 30330, United States

RECRUITING

CenExel iResearch Savannah

Savannah, Georgia, 31405, United States

RECRUITING

Great Lakes Clinical Trials, DBA Flourish Research

Chicago, Illinois, 60640, United States

RECRUITING

Uptown Research Institute

Chicago, Illinois, 60640, United States

RECRUITING

Psychiatric Medicine Associates, LLC

Skokie, Illinois, 60076, United States

RECRUITING

Atlas Psychiatric

New Orleans, Louisiana, 70115, United States

NOT YET RECRUITING

DelRicht Research

New Orleans, Louisiana, 70115, United States

RECRUITING

Sunstone Medical, PC

Rockville, Maryland, 20850, United States

RECRUITING

Adams Clinical Boston

Boston, Massachusetts, 02116, United States

RECRUITING

Adams Clinical

Boston, Massachusetts, 02472, United States

RECRUITING

Elixia Health

Springfield, Massachusetts, 01103, United States

RECRUITING

Redbird Research, LLC

Las Vegas, Nevada, 89119, United States

RECRUITING

Oasis Clinical Trials

Las Vegas, Nevada, 89121, United States

TERMINATED

Global Medical Institutes, Princeton Medical Institute

Princeton, New Jersey, 08540, United States

RECRUITING

Adams Clinical Harlem

New York, New York, 100029, United States

RECRUITING

Adams Clinical Bronx

The Bronx, New York, 10461, United States

RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

RECRUITING

Neurobehavioral Clinical Research

North Canton, Ohio, 44720, United States

RECRUITING

Clinical Neuroscience Solutions, CNS Healthcare

Memphis, Tennessee, 38119, United States

RECRUITING

InSite Clinical Research, LLC

DeSoto, Texas, 75115, United States

RECRUITING

Zillan Clinical Research

Houston, Texas, 77433, United States

RECRUITING

AIM Trials

Plano, Texas, 75093, United States

WITHDRAWN

Cedar Clinical Research

Murray, Utah, 84107, United States

RECRUITING

Inner Space Research, LLC

Orem, Utah, 84058, United States

RECRUITING

Related Links

• Apply for Trial Here

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Clinical Development

  Cybin IRL Limited

  STUDY CHAIR

Central Study Contacts

Clinical Development

CONTACT

877-361-4003; clinicaltrialsinfo@cybin.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 21, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (46)