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Magic Mushroom-Derived drug enters final trial for depression

NCT ID NCT06793397

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 12 times

Summary

This Phase 3 study tests whether CYB003, a psilocin analog (related to the active ingredient in magic mushrooms), can safely reduce depression symptoms in 330 adults with major depressive disorder. Participants receive either one of two doses of CYB003 or a placebo, along with psychological support. The main goal is to see if the drug improves depression scores over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CYB003 (a psilocin analog)
What this could lead to
If successful, this could provide a new treatment option for people with major depression who haven't responded well to standard antidepressants.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects (including psychological effects) are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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 330 people

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

Started

Dec 2025

Expected to finish

May 2027

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: * Age18 to 85 years. * 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. * Moderate to severe depression at Screening and Baseline, independently confirmed. * Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks 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). * 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 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. * Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. * Participants have 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 antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are 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 (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. * Participants have a presence or relevant history of organic brain disorders. * Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration. * Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing. * 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.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

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

Depression Depression - major depressive disorder Depression disorder Depression disorders Depression in adults Major depressive disorder (MDD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    63 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A-SHINE s.r.o.

    NOT_YET_RECRUITING

    Předměstí, Czechia

  • ATP Clinical Research

    RECRUITING

    Orange, California, 92866, United States

  • Accel Research Sites - Maitland

    RECRUITING

    Maitland, Florida, 32751, United States

  • Adams Clinical Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Aqualane Clinical Research

    RECRUITING

    Naples, Florida, 34105, United States

  • Ascend Clinical Research

    RECRUITING

    Reading, RG7 8PA, United Kingdom

  • Atlas Psychiatry

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • Attikon University Hospital

    RECRUITING

    Athens, 12462, Greece

  • Austin Clinical Trial Partners

    NOT_YET_RECRUITING

    Austin, Texas, 78737, United States

    Contact Email: •••••@•••••

  • Behavioral Research Specialists, LLC

    RECRUITING

    Glendale, California, 91206, United States

  • Bio Behavioral Health

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • Brain Health Consultants and TMS Center

    RECRUITING

    Houston, Texas, 77046, United States

    Contact Email: •••••@•••••

  • CNS Healthcare

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • CalNeuro Research Group

    RECRUITING

    Los Angeles, California, 90025, United States

    Contact Email: •••••@•••••

  • Cambridge University Hospital NHS

    RECRUITING

    Cambridge, CB1 2EU, United Kingdom

  • Central Institute of Mental Health

    NOT_YET_RECRUITING

    Mannheim, 68159, Germany

  • Centrum Badan Klinicznych PI-House Sp. z o.o

    RECRUITING

    Gdansk, 80-546, Poland

  • Charité Universitaetsmedizin Berlin

    NOT_YET_RECRUITING

    Berlin, 10117, Germany

  • Clerkenwell Health - Baker Street

    RECRUITING

    London, W1U 6RP, United Kingdom

  • Clerkenwell Health - Doncaster

    RECRUITING

    Doncaster, DN4 8QN, United Kingdom

  • Clerkenwell Health - Welbeck Street

    WITHDRAWN

    London, W1G 8DR, United Kingdom

  • Core Clinical Research

    NOT_YET_RECRUITING

    Everett, Washington, 98201, United States

  • Department of Pharmacology and Physiology of CNS

    NOT_YET_RECRUITING

    Warsaw, 02-957, Poland

  • Edwardson Building - Campus for Ageing and Vitality

    RECRUITING

    Newcastle upon Tyne, NE4 5PL, United Kingdom

  • Eginitio Hospital

    RECRUITING

    Athens, 11528, Greece

  • Emory University Dept of Psychiatry and Behavioral Studies

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30329, United States

  • Flourish Research Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19462, United States

  • Flourish Research San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Inland Psychiatric Medical Group Inc (IPMG Research)

    NOT_YET_RECRUITING

    San Juan Capistrano, California, 92675, United States

    Contact Email: •••••@•••••

  • Institute for Integrative Therapies

    RECRUITING

    Eden Prairie, Minnesota, 55347, United States

  • Institute of neuropsychiatric Care (INEP)

    NOT_YET_RECRUITING

    Prague, Czechia

    Contact Email: •••••@•••••

  • Johns Hopkins Medicine

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21224, United States

  • King's College London

    RECRUITING

    London, SE5 9RS, United Kingdom

  • La Nua Day Hospital Mental Health Centre

    RECRUITING

    Galway, H91 VE03, Ireland

  • Lighthouse Psychiatry

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • MTZ Clinical Research Powered by Pratia

    RECRUITING

    Warsaw, 02-172, Poland

  • Monash University - Notting Hill

    RECRUITING

    Notting Hill, Victoria, 3168, Australia

  • NHS Research Scotland

    NOT_YET_RECRUITING

    Edinburgh, EH16 4TJ, United Kingdom

  • NRC Research Institute

    RECRUITING

    Orange, California, 92868, United States

  • Neurocentrix Research

    RECRUITING

    Melbourne, Victoria, 3053, Australia

  • New York State Psychiatric Institute

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • North Texas Clinical Trials

    WITHDRAWN

    Fort Worth, Texas, 76104, United States

  • Papageorgiou General Hospital

    RECRUITING

    Thessaloniki, 56404, Greece

  • Pillar Clinical Research - Little Rock

    WITHDRAWN

    Little Rock, Arkansas, 72204, United States

  • Promente - Centrum Neurologii i Psychogeriatrii w Bydgoszczy

    RECRUITING

    Bydgoszcz, 85-133, Poland

  • Psych Atlanta

    RECRUITING

    Marietta, Georgia, 30060, United States

    Contact Email: •••••@•••••

  • Psychedelic Science Institute

    RECRUITING

    Santa Monica, California, 90404, United States

    Contact Email: •••••@•••••

  • Psyon s.r.o.

    NOT_YET_RECRUITING

    Prague, Czechia

    Contact Email: •••••@•••••

  • Queen Elizabeth University Hospital

    NOT_YET_RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Ramsay Clinic

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Re:Cognition Health

    RECRUITING

    London, W1G9 RU, United Kingdom

  • Redbird Research, LLC

    RECRUITING

    Las Vegas, Nevada, 89119, United States

    Contact Email: •••••@•••••

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Rush University

    RECRUITING

    Chicago, Illinois, 60612, United States

  • SP Research PLLC

    WITHDRAWN

    Oklahoma City, Oklahoma, 73112, United States

  • Seattle Neuropsychiatric Treatment Center

    RECRUITING

    Seattle, Washington, 98104, United States

    Contact Email: •••••@•••••

  • Sheaf House - Tallaght Adult Mental Health Service

    RECRUITING

    Dublin, D24 WK80, Ireland

  • Sheffield Health and Social Care NHS Foundation Trust

    RECRUITING

    Sheffield, S4 7QQ, United Kingdom

  • St Pancras Clinical Research

    RECRUITING

    London, EC2Y 8EA, United Kingdom

  • Stanford University

    WITHDRAWN

    Stanford, California, 94305, United States

  • Sun Valley Research Center

    WITHDRAWN

    Imperial, California, 92251, United States

  • Tandem Clinical Research

    NOT_YET_RECRUITING

    Marrero, Louisiana, 70006, United States

  • Thompson Brain & Mind Healthcare (TBMH)

    RECRUITING

    Maroochydore, Queensland, 4558, Australia

  • UAB Psychiatry and Behavioral Neurology

    RECRUITING

    Birmingham, Alabama, 35209, United States

    Contact Email: •••••@•••••

  • UCK

    NOT_YET_RECRUITING

    Gdansk, 80-214, Poland

  • University Hospital Frankfurt

    NOT_YET_RECRUITING

    Frankfurt am Main, 60528, Germany

  • Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes

    NOT_YET_RECRUITING

    Homburg, Saarland, 66421, Germany

  • Uniwersytecki Szpital Kliniczny W Białymstoku

    NOT_YET_RECRUITING

    Bialystok, 15-272, Poland

  • Yale School of Medicine - Yale Program for Psychedelic Science

    RECRUITING

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.