New depression pill CYB003 enters final testing phase

NCT ID NCT06564818

Symptom relief Sponsor: Cybin IRL Limited Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study tests an experimental oral drug called CYB003 in 220 adults with major depressive disorder. Participants receive either CYB003 or a placebo alongside their usual treatment. The goal is to see if CYB003 safely reduces depression symptoms better than placebo.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. * Female participants who were capable of producing eggs (ova) must agree that the only exclusion from the requirement for contraception during the trial is to be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle-stimulating hormone level in the menopausal range, unless the participant is taking hormone replacement therapy or is using hormonal contraception. * Participant has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form. 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, 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. * Participant has a presence or relevant history of organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions). * Known sensitivity to psilocin and/or any excipients present in the formulation. * Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within 14 days prior to trial medication administration. * The participant has participated in a clinical trial and has received a medication or a new chemical entity within 12 weeks prior to dosing with the current trial medication. Participants who have completed observational or non-interventional studies will be allowed. * Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing. * Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing. * History of serotonin syndrome. * Unwilling to consent to audio and video recording of psychological support and dosing sessions. * Staff and family members of Cybin IRL Limited, investigator sites, contract research organization or other vendors.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

Adams Clinical

Boston, Massachusetts, 02472, United States
Adams Clinical Boston

Boston, Massachusetts, 02116, United States
Adams Clinical Bronx

The Bronx, New York, 10461, United States
Adams Clinical Harlem

New York, New York, 100029, United States
Adams Clinical Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Atlanta Center for Medical Research, CenExel

Atlanta, Georgia, 30331, United States
Bespoke Treatment/Lipov Medical Group

Los Angeles, California, 90025, United States
Catalina Research Institute

Montclair, California, 91763, United States
Cedar Clinical Research

Murray, Utah, 84107, United States
CenExel CIT (Clinical Innovations, Inc)

Bellflower, California, 90706, United States
CenExel iResearch Atlanta

Decatur, Georgia, 30330, United States
CenExel iResearch Savannah

Savannah, Georgia, 31405, United States
Charter Research

Orlando, Florida, 32803, United States
Clinical Neuroscience Solutions, CNS Healthcare

Memphis, Tennessee, 38119, United States
Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States
Combined Research Orlando Phase I-IV

Orlando, Florida, 32807, United States
Del Sol Research Management

Tucson, Arizona, 85715, United States
DelRicht Research

New Orleans, Louisiana, 70115, United States
Elixia Health

Springfield, Massachusetts, 01103, United States
Excell Research, Inc

Oceanside, California, 92056, United States
Floridian Neuroscience Institute

Miami, Florida, 33135, United States
Global Medical Institutes, Princeton Medical Institute

Princeton, New Jersey, 08540, United States
Great Lakes Clinical Trials, DBA Flourish Research

Chicago, Illinois, 60640, United States
InSite Clinical Research, LLC

DeSota, Texas, 75115, United States
Inland Psychiatric Medical Group Inc

San Juan Capistrano, California, 92675, United States
Inner Space Research, LLC

Orem, Utah, 84058, United States
K2 Medical Research - Tampa

Tampa, Florida, 33634, United States
K2 Medical Research-Maitland

Maitland, Florida, 32751, United States
Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States
Monroe Biomedical Research

Monroe, North Carolina, 28112, United States
Mountain Clinical Trials

Phoenix, Arizona, 85050, United States
Mountain View Clinical Research

Denver, Colorado, 80209, United States
Neurobehavioral Clinical Research

North Canton, Ohio, 44720, United States
Noble Clinical Research

Tucson, Arizona, 85704, United States
Oasis Clinical Trials

Las Vegas, Nevada, 89121, United States
Open Mind Therapeutics

San Francisco, California, 94114, United States
Psychiatric Medicine Associates, LLC

Skokie, Illinois, 60076, United States
Redbird Research, LLC

Las Vegas, Nevada, 89119, United States
Research Centers of America

Hollywood, Florida, 33024, United States
Scottsdale Research Institute

Phoenix, Arizona, 85022, United States
Segal Trials West Broward

North Miami, Florida, 33161, United States
Starlight Clinical Research

Evergreen, Colorado, 80439, United States
Sunstone Medical, PC

Rockville, Maryland, 20850, United States
Uptown Research Institute

Chicago, Illinois, 60640, United States
Zillan Clinical Research

Houston, Texas, 77433, United States

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