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

June 1, 2026 updated by: Cybin IRL Limited

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

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.

For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Principal Investigator:
          • Nicholas Glozier
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Recruiting
        • Thompson Brain & Mind Healthcare (TBMH)
        • Principal Investigator:
          • Adem Can
        • Contact:
        • Contact:
    • Victoria
      • Melbourne, Victoria, Australia, 3004
      • Melbourne, Victoria, Australia, 3053
      • Notting Hill, Victoria, Australia, 3168
        • Recruiting
        • Monash University - Notting Hill
        • Contact:
        • Principal Investigator:
          • Paul Liknaitzky
  • Czechia
      • Prague, Czechia
        • Not yet recruiting
        • Institute of neuropsychiatric Care (INEP)
        • Principal Investigator:
          • Alexander Nawka
        • Contact:
      • Prague, Czechia
        • Not yet recruiting
        • Psyon s.r.o.
        • Principal Investigator:
          • Tomas Palenicek
        • Contact:
      • Předměstí, Czechia
        • Not yet recruiting
        • A-SHINE s.r.o.
        • Principal Investigator:
          • Lubos Janu
        • Contact:
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charité Universitaetsmedizin Berlin
        • Principal Investigator:
          • Michael Koslowski
        • Contact:
      • Frankfurt am Main, Germany, 60528
        • Not yet recruiting
        • University Hospital Frankfurt
        • Principal Investigator:
          • Andreas Reif
        • Contact:
      • Mannheim, Germany, 68159
        • Not yet recruiting
        • Central Institute of Mental Health
        • Contact:
        • Principal Investigator:
          • Gerhard Grüender
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Not yet recruiting
        • Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes
        • Principal Investigator:
          • Matthias Riemenschneider
        • Contact:
        • Contact:
  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • Attikon University Hospital
        • Principal Investigator:
          • Nikolaos Smyrnis
        • Contact:
      • Athens, Greece, 11528
        • Recruiting
        • Eginitio Hospital
        • Principal Investigator:
          • Nikos Stefanis
        • Contact:
      • Thessaloniki, Greece, 56404
        • Recruiting
        • Papageorgiou General Hospital
        • Principal Investigator:
          • Georgios Papazisis
        • Contact:
  • Ireland
      • Dublin, Ireland, D24 WK80
        • Recruiting
        • Sheaf House - Tallaght Adult Mental Health Service
        • Principal Investigator:
          • John Kelly
        • Contact:
      • Galway, Ireland, H91 VE03
        • Recruiting
        • La Nua Day Hospital Mental Health Centre
        • Contact:
        • Principal Investigator:
          • Shane McInerney
  • Poland
      • Bialystok, Poland, 15-272
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny w Białymstoku
        • Principal Investigator:
          • Napoleon Waszkiewicz
        • Contact:
      • Bydgoszcz, Poland, 85-133
        • Recruiting
        • Promente - Centrum Neurologii i Psychogeriatrii w Bydgoszczy
        • Contact:
        • Principal Investigator:
          • Katarzyna Lachut
      • Gdansk, Poland, 80-214
        • Not yet recruiting
        • UCK
        • Principal Investigator:
          • Wieslaw Jerzy Cubala
        • Contact:
      • Gdansk, Poland, 80-546
        • Not yet recruiting
        • Centrum Badan Klinicznych PI-House Sp. z o.o
        • Contact:
        • Principal Investigator:
          • Hanna Badzio-Jagiello
      • Warsaw, Poland, 02-172
        • Not yet recruiting
        • MTZ Clinical Research Powered by Pratia
        • Principal Investigator:
          • Monika Gawlowicz
      • Warsaw, Poland, 02-957
        • Not yet recruiting
        • Department of Pharmacology and Physiology of CNS
        • Principal Investigator:
          • Justyna Holka-Pokorska
  • United Kingdom
      • Cambridge, United Kingdom, CB1 2EU
        • Recruiting
        • Cambridge University Hospital NHS
        • Principal Investigator:
          • Liliana Galindo
        • Contact:
        • Contact:
      • Doncaster, United Kingdom, DN4 8QN
        • Recruiting
        • Clerkenwell Health - Doncaster
        • Principal Investigator:
          • Paul Morrison
        • Contact:
      • Edinburgh, United Kingdom, EH16 4TJ
        • Not yet recruiting
        • NHS Research Scotland
        • Principal Investigator:
          • Donald MacIntyre
        • Contact:
      • Glasgow, United Kingdom, G51 4TF
      • London, United Kingdom, EC2Y 8EA
        • Not yet recruiting
        • St Pancras Clinical Research
        • Principal Investigator:
          • Martin Johnson
        • Contact:
      • London, United Kingdom, W1G 8DR
      • London, United Kingdom, W1U 6RP
      • London, United Kingdom, W1G9 RU
        • Recruiting
        • Re:Cognition Health
        • Principal Investigator:
          • Dimitrios Paschos
        • Contact:
          • Phone Number: +44-0800-802-1030
      • London, United Kingdom, SE5 9RS
      • Newcastle upon Tyne, United Kingdom, NE4 6BE
        • Not yet recruiting
        • Wolfson Unit - Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Mourad Wahba
        • Contact:
      • Reading, United Kingdom, RG7 8PA
        • Recruiting
        • Ascend Clinical Research
        • Principal Investigator:
          • Pamela Walters
        • Contact:
      • Sheffield, United Kingdom, S4 7QQ
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • UAB Psychiatry and Behavioral Neurology
        • Principal Investigator:
          • Peter Hendricks
        • Contact:
    • Arizona
      • Gilbert, Arizona, United States, 85234
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Not yet recruiting
        • Pillar Clinical Research - Little Rock
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leslie Smith
    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • Behavioral Research Specialists, LLC
        • Principal Investigator:
          • Jesse Carr
        • Contact:
      • Imperial, California, United States, 92251
        • Not yet recruiting
        • Sun Valley Research Center
        • Principal Investigator:
          • Bernardo Ng
        • Contact:
      • Los Angeles, California, United States, 90025
        • Recruiting
        • CalNeuro Research Group
        • Principal Investigator:
          • Alexander Bystritsky
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • NRC Research Institute
        • Contact:
        • Principal Investigator:
          • Daniel Chueh
      • Orange, California, United States, 92866
        • Recruiting
        • ATP Clinical Research
        • Principal Investigator:
          • Gustavo Alva
        • Contact:
      • San Juan Capistrano, California, United States, 92675
        • Not yet recruiting
        • Inland Psychiatric Medical Group Inc (IPMG Research)
        • Principal Investigator:
          • Neelima Kunam
        • Contact:
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Psychedelic Science Institute
        • Principal Investigator:
          • Keith Heinzerling
        • Contact:
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Charles DeBattista
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale School of Medicine - Yale Program for Psychedelic Science
        • Principal Investigator:
          • Ben Kelmendi
        • Contact:
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • CNS Healthcare
        • Contact:
          • Phone Number: 904-281-5757
        • Principal Investigator:
          • John Mark Joyce
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Accel Research Sites - Maitland
        • Contact:
          • Phone Number: 407-644-1165
        • Principal Investigator:
          • Andrea Marrafino
      • Naples, Florida, United States, 34105
        • Recruiting
        • Aqualane Clinical Research
        • Principal Investigator:
          • Matthew Baker
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Not yet recruiting
        • Emory University Dept of Psychiatry and Behavioral Studies
        • Contact:
        • Principal Investigator:
          • Ali John Zarrabi
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Psych Atlanta
        • Principal Investigator:
          • Michael Banov
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University
        • Principal Investigator:
          • Joshua Eloge
        • Contact:
    • Louisiana
      • Marrero, Louisiana, United States, 70006
        • Not yet recruiting
        • Tandem Clinical Research
        • Principal Investigator:
          • Angela Traylor
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Not yet recruiting
        • Johns Hopkins Medicine
        • Contact:
        • Principal Investigator:
          • Albert Garcia-Romeu
    • Minnesota
      • Eden Prairie, Minnesota, United States, 55347
        • Recruiting
        • Institute for Integrative Therapies
        • Principal Investigator:
          • Manoj Doss
        • Contact:
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Bio Behavioral Health
        • Contact:
        • Principal Investigator:
          • Ashok Patel
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • New York State Psychiatric Institute
        • Principal Investigator:
          • Natalie Gukasyan
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Not yet recruiting
        • SP Research PLLC
        • Principal Investigator:
          • Marvin Peyton
        • Contact:
          • Phone Number: 405-753-4994
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Adams Clinical Philadelphia
        • Principal Investigator:
          • Cassie Blanchard
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19462
        • Recruiting
        • Flourish Research Philadelphia
        • Principal Investigator:
          • Rachna Saralkar
        • Contact:
          • Phone Number: 215-614-5606
    • Texas
      • Austin, Texas, United States, 78737
        • Not yet recruiting
        • Austin Clinical Trial Partners
        • Principal Investigator:
          • Don Garcia
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • North Texas Clinical Trials
        • Contact:
        • Principal Investigator:
          • Diana Ghelber
      • Houston, Texas, United States, 77046
        • Recruiting
        • Brain Health Consultants and TMS Center
        • Principal Investigator:
          • Lauren Marangell
        • Contact:
      • San Antonio, Texas, United States, 78229
    • Washington
      • Everett, Washington, United States, 98201
        • Not yet recruiting
        • Core Clinical Research
        • Contact:
        • Principal Investigator:
          • James Knutson
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Seattle Neuropsychiatric Treatment Center
        • Principal Investigator:
          • Rebecca Allen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm A CYB003 in 2 of 2 Dosing Sessions
Arm A participants will receive 8 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.
Behavioral: Psychological Support
Manualized psychological support performed by facilitator.
Drug: CYB003
CYB003 is a deuterated psilocin analog.
Experimental: Experimental Arm B CYB003 in 2 of 2 Dosing Sessions
Experimental Arm B participants will receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm B participants will continue on their current antidepressants and receive psychological support throughout the study.
Behavioral: Psychological Support
Manualized psychological support performed by facilitator.
Drug: CYB003
CYB003 is a deuterated psilocin analog.
Placebo Comparator: Placebo Comparator: Arm C Placebo in 2 of 2 Dosing Session
Participants will receive placebo in 2 of 2 medicine sessions, approximately three weeks apart. All Arm C 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
Manualized psychological support performed by facilitator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Scale (MADRS)
Time Frame: Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.

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

The total score ranges 0-60, higher scores denote greater severity.
Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Beck Depression Inventory - Second Edition (BDI-II)
Time Frame: Day -1, Day 21, Day 42 and Day 84/End of Trial.

The Beck Depression Inventory-Second Edition (BDI-II) is a 21-question multiple-choice self-report inventory, assessing depressive symptoms and severity.

Each question is scored on a scale value of 0 to 3, with higher total scores indicating more severe depressive symptoms. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the BDI-II, so the total score possible is 63 and minimum if everything is zero would be 0.
Day -1, Day 21, Day 42 and Day 84/End of Trial.
The Clinical Global Impression Scale (CGI-S)
Time Frame: Screening Day-45, Baseline Day -1, Day 42, Day 84/End of Trial.

The Clinical Global Impression Scale is a clinician-rated instrument comprised of 3 global measures: severity of illness, global improvement and efficacy index.

Only the severity of illness ang global improvement measures will be utilized for this trial.

Higher score means more severe symptomology, worse outcome. CGI-S scoring is as follows:

  1. = Normal, not at all ill
  2. = Borderline ill
  3. = Mildly ill
  4. = Moderately ill
  5. = Markedly ill
  6. = Severely ill
  7. = Among the most extremely ill patients
Screening Day-45, Baseline Day -1, Day 42, Day 84/End of Trial.
The Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time Frame: Baseline Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.

The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a 7-item self reported assessment that measures the severity of generalized anxiety disorder symptoms.

Participants respond to each item using a 4-point scale from 0 to 3. Participants choose one of 4 severity scores associated with problems related to the common anxiety disorders to indicate the degree to which these problems caused functional and/or social difficulties. A total score is obtained by the sum of all total column values, higher scores indicate more functional/social impairment/difficulties. Score range is as follows:

Scores represent:

0 - 4 = Minimal anxiety 5 - 9 = Mild anxiety 10 - 14 = Moderately anxiety 15 - 21 = Severe anxiety
Baseline Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Time Frame: Day -1, Day 21, Day 42 and Day 84/End of Trial.

The original Quality of Life Enjoyment and Satisfaction Questionnaire is a 93 item, participant facing, self reported measure used to evaluate intervention-related changes in quality of life, divided int the following sections: physical health, feelings, work, household duties, school, leisure time activities, social relations and general activities.

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) version will be used in this trial.

Each item rated on a 5-point scale ranging from 1 (very poor) to 5 (very good), higher score indicates greater satisfaction. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. So the minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70
Day -1, Day 21, Day 42 and Day 84/End of Trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cybin IRL Limited

Collaborators

Worldwide Clinical Trials

Investigators

  • Study Director: Felix Mazer, Cybin IRL Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

March 18, 2027

Study Completion (Estimated)

May 8, 2027

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYB003-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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