Major Depressive Disorder (MDD)Phase 3EMBRACENCT06793397
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
A Phase 3 study testing CYB003 and Psychological Support in people with Major Depressive Disorder (MDD) and Depression in Adults, run by Cybin IRL Limited at 79 sites in 8 countries.
Trial 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. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder
- What is being tested?
- CYB003 and Psychological Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 79 sitesin 8 countries
- Study dates
- 10 Dec 2025to 9 Aug 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
79 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
79 sites in 8 countries
United States43 sites, 34 recruiting
- Withdrawn
Emory University Dept of Psychiatry and Behavioral Studies
Atlanta, Georgia, 30329
- Withdrawn
Austin Clinical Trial Partners
Austin, Texas, 78737
- Withdrawn
Johns Hopkins Medicine
Baltimore, Maryland, 21224
- Recruiting
UAB Psychiatry and Behavioral Neurology
Birmingham, Alabama, 35209
Seher Premani, 205-996-1198, spremani@uab.edu
Maggie Gossage, mgossage@uabmc.edu
- Recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
Darin Dougherty, MD, 617-934-5733, ddougherty@adamsclinical.com
- Recruiting
Rush University
Chicago, Illinois, 60612
Stephanie Gutierrez, 312-942-8995, stephanie_z_gutierrez@rush.edu
Joshua Eloge
- Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Camille Condron, 972-283-6286, ccondron@adamsclinical.com
Rajinder Shiwach
- Recruiting
Institute for Integrative Therapies
Eden Prairie, Minnesota, 55347
Sena Ostwalt, 6512808774, sena.ostwalt@iit-mn.com
Manoj Doss
- Not yet recruiting
Core Clinical Research
Everett, Washington, 98201
Maria Golescu, 425-443-9551, maria.golescu@ccrtrial.com
James Knutson
- Withdrawn
North Texas Clinical Trials
Fort Worth, Texas, 76104
- Recruiting
Lighthouse Psychiatry
Gilbert, Arizona, 85234
Chung Trinh, 435-268-5800, ctrinh@neosciclinicalresearch.com
Frank Genova
- Recruiting
Behavioral Research Specialists, LLC
Glendale, California, 91206
Laisha Uribe, 888-255-5798, laisha@brstrials.com
Jesse Carr
- Not yet recruiting
The Remedy Mental Health
Golden Valley, Minnesota, 55427
Emmanuel Arhin, (651) 382-9518, emmanuel.arhin@theremedymn.com
Wayne Bentham
- Recruiting
Brain Health Consultants and TMS Center
Houston, Texas, 77046
713-489-5000, info@brainhealthconsultants.com
Lauren Marangell
- Withdrawn
Sun Valley Research Center
Imperial, California, 92251
- Recruiting
CNS Healthcare
Jacksonville, Florida, 32256
904-281-5757
John Mark Joyce
- Recruiting
Redbird Research, LLC
Las Vegas, Nevada, 89119
702-577-2000, info@redbird-research.com
Jelena Kunovac
- Withdrawn
Pillar Clinical Research - Little Rock
Little Rock, Arkansas, 72204
- Recruiting
CalNeuro Research Group
Los Angeles, California, 90025
310-208-7144, info@calneuroresearch.com
Alexander Bystritsky
- Not yet recruiting
Lipov Medical Group
Los Angeles, California, 90025
Brittany Juhlmann, 262-352-8835, brittany.juhlmann@stellacenter.com
Jacob Moussai
- Recruiting
Accel Research Sites - Maitland
Maitland, Florida, 32751
407-644-1165
Andrea Marrafino
- Recruiting
Psych Atlanta
Marietta, Georgia, 30060
770-422-2846, research@hightophealth.com
Michael Banov
- Withdrawn
Tandem Clinical Research
Marrero, Louisiana, 70006
- Recruiting
Aqualane Clinical Research
Naples, Florida, 34105
Rachel Novella, 239-529-6780, Rachel@Aqualaneresearch.com
Matthew Baker
- Recruiting
Yale School of Medicine - Yale Program for Psychedelic Science
New Haven, Connecticut, 06511
Daidre Chamberlain, 203-693-1591, enact@yale.edu
Terrence Ching, 502-612-1127, terence.ching@yale.edu
- Recruiting
Atlas Psychiatry
New Orleans, Louisiana, 70115
Milton Boresoff, 504-899-1682, m.boresoff@atlaspsychiatry.com
Nicholas Pejic
- Recruiting
Adams Clinical Harlem
New York, New York, 10029
Kayla Collins, 917-423-6797, kcollins@adamsclinical.com
Rachel Noone
- Not yet recruiting
New York State Psychiatric Institute
New York, New York, 10032
Alexandra Mackay, 212-342-1424, alexandra.mackay@nyspi.columbia.edu
Natalie Gukasyan
- Withdrawn
SP Research PLLC
Oklahoma City, Oklahoma, 73112
- Recruiting
ATP Clinical Research
Orange, California, 92866
Sarah Perkins, 949-354-5353, sarahp@pnsoc.com
Gustavo Alva
- Recruiting
NRC Research Institute
Orange, California, 92868
Christian Ortiz, 714-289-1100, cortiz@nrcresearch.com
Daniel Chueh
- Recruiting
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104
267-207-2511, info@adamsclinical.com
Cassie Blanchard
- Recruiting
Flourish Research Philadelphia
Philadelphia, Pennsylvania, 19462
215-614-5606
Rachna Saralkar
- Not yet recruiting
Sunstone Medical, PC
Rockville, Maryland, 20850
Manish Agrawal, MD, 301-750-3401, Manish.agrawal@sunstonetherapies.com
- Recruiting
Flourish Research San Antonio
San Antonio, Texas, 78229
Xavier Martinez, 210-949-0122 ext. 237, xmartinez@flourishresearch.com
Andrea Gomez, 210-949-0122 ext. 122, agomez@flourishresearch.com
- Not yet recruiting
Inland Psychiatric Medical Group Inc (IPMG Research)
San Juan Capistrano, California, 92675
909-955-5865, research@inlandpsych.com
Neelima Kunam
- Recruiting
Psychedelic Science Institute
Santa Monica, California, 90404
213-973-7512, trialadmin@psychedelicsci.com
Keith Heinzerling
- Recruiting
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104
206-467-6300 ext. 5, research@seattlentc.com
Rebecca Allen
- Withdrawn
Stanford University
Stanford, California, 94305
- Recruiting
K2 Medical Research Tampa
Tampa, Florida, 33634
Jessica Myers, 352-500-5252, Jessica.Myers@k2med.com
Kelley Wilson
- Recruiting
Davis Clinical (Adams Clinical Bronx)
The Bronx, New York, 10461
Daniela Grimard, 646-970-7804, dgrimard@adamsclinical.com
Shama Farooq
- Recruiting
Bio Behavioral Health
Toms River, New Jersey, 08755
Jessica Sutton, 732-244-2299, jessica@bbhnj.com
Ashok Patel
- Recruiting
Adams Clinical Watertown
Watertown, New York, 02472
Stephanie Ellickson, 574 514-4554, sellickson@adamsclinical.com
United Kingdom13 sites, 12 recruiting
- Recruiting
Cambridge University Hospital NHS
Cambridge, CB1 2EU
Tracy Assari, +44 1223 219751, t.assari@nhs.net
Emma Tudor, +44 1223 219751, Emma.tudor@cpft.nhs
- Recruiting
Clerkenwell Health - Doncaster
Doncaster, DN4 8QN
Celia Creaghan, +44 7849 640886, ccreaghan@clerkenwellhealth.com
Paul Morrison
- Not yet recruiting
NHS Research Scotland
Edinburgh, EH16 4TJ
Carrie Wardhaugh, +44 1315375867, carrie.wardhaugh@ed.ac.uk
Donald MacIntyre
- Not yet recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Rebecca Baird, ggc.mentalhealthresearch@nhs.scot
Maytal Wolfe
- Recruiting
St Pancras Clinical Research
London, EC2Y 8EA
Katherine Nuttall, +44 20 38651142, katherinenuttall@stpancrasclinical.com
Martin Johnson
- Recruiting
King's College London
London, SE5 9RS
Catheine Bird, catherine.bird@kcl.ac.uk
Paige Seath, paige.seath@kcl.ac.uk
- Withdrawn
Clerkenwell Health - Welbeck Street
London, W1G 8DR
- Recruiting
Re:Cognition Health
London, W1G9 RU
+44-0800-802-1030
Dimitrios Paschos
- Recruiting
Clerkenwell Health - Baker Street
London, W1U 6RP
Victor Jardim, +44 2038974867, vjardim@clerkenwellhealth.com
Takunda Gwenhure, +44 2038974867, tgwenhure@clerkenwellhealth.com
- Recruiting
Edwardson Building - Campus for Ageing and Vitality
Newcastle upon Tyne, NE4 5PL
Victoria Wilson, +44 191 246 8647, victoria.wilson3@cntw.nhs.uk
Rebecca Woodhouse, Rebecca.Woodhouse@cntw.nhs.uk
- Recruiting
Ascend Clinical Research
Reading, RG7 8PA
Alexandra Diaz, +44 118 3045905, adiaz@ascendclinical-research.com
Pamela Walters
- Recruiting
Sheffield Health and Social Care NHS Foundation Trust
Sheffield, S4 7QQ
Mishell Cunningham, +44 114 271 6731, mishell.cunningham@sheffieldpartnership.nhs.uk
William Gann
- Not yet recruiting
Hollins Park Hospital, Winwick
Warrington, WA2 8WA
Rachel Crick, +44730 861 3597, Rachel.Crick@merseycare.nhs.uk
Fabian Devlin
Poland6 sites, 5 recruiting
- Withdrawn
Uniwersytecki Szpital Kliniczny W Białymstoku
Bialystok, 15-272
- Recruiting
Promente - Centrum Neurologii i Psychogeriatrii w Bydgoszczy
Bydgoszcz, 85-133
Franciszek Lauchut, +48 790 219 501, f.lachut@pro-mente.pl
Katarzyna Lachut
- Not yet recruiting
UCK
Gdansk, 80-214
Natalia Sudol, +48 669 439 740, nat.sudol13@gmail.com
Wieslaw Jerzy Cubala
- Recruiting
Centrum Badan Klinicznych PI-House Sp. z o.o
Gdansk, 80-546
Monika Drzewiecka, +48 508-348-938, m.drzewiecka@pihouse.pl
Hanna Badzio-Jagiello
- Recruiting
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
Monika Gawlowicz
- Not yet recruiting
Department of Pharmacology and Physiology of CNS
Warsaw, 02-957
Justyna Holka-Pokorska
Australia5 sites, 5 recruiting
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Nicholas Glozier
- Recruiting
Thompson Brain & Mind Healthcare (TBMH)
Maroochydore, Queensland, 4558
Megan Dutton, +61 4160 40977, mdutton@tbmh.org.au
Kristy Smyth, +61 4324 41227, ksmyth@tbmh.org.au
- Recruiting
Ramsay Clinic
Melbourne, Victoria, 3004
Melanie Hurley, 03 9279 3569, research.arc@ramsayhealth.com.au
Grace Monigatti, 03 9279 3569, research.arc@ramsayhealth.com.au
- Recruiting
Neurocentrix Research
Melbourne, Victoria, 3053
Mai-Anh Bui, +61 3 9546 0009, mai@neurocentrix.com.au
Gabriela Gonzalez, +61 3 9959 8375, gabriela@neurocentrix.com.au
- Recruiting
Monash University - Notting Hill
Notting Hill, Victoria, 3168
Olivia Lavalette, 0426359494, olivia.lavalette@monash.edu
Paul Liknaitzky
Germany4 sites, 4 recruiting
- Not yet recruiting
Charité Universitaetsmedizin Berlin
Berlin, 10117
+49 30 450 617734, psychedelika-studien@charite.de
Michael Koslowski
- Not yet recruiting
University Hospital Frankfurt
Frankfurt am Main, 60528
Tanja Scharf, +49 69 6301 86078, tanja.scharf@unimedizin-ffm.de
Andreas Reif
- Not yet recruiting
Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes
Homburg, Saarland, 66421
Christine Geiger, +49 6841 1624227, christine.geiger@uks.eu
Aline Freer, +49 6841 1614219, aline.freer@uks.eu
- Not yet recruiting
Central Institute of Mental Health
Mannheim, 68159
Karin Bopp, +49 621 1703 3163 ext. 3016, Karin.bopp@zi-mannheim.de
Gerhard Grüender
Czechia3 sites, 3 recruiting
- Not yet recruiting
Institute of neuropsychiatric Care (INEP)
Prague
+420 222 201 020, info@inep.cz
Alexander Nawka
- Not yet recruiting
Psyon s.r.o.
Prague
+420 774 401 161, info@psyon.cz
Tomas Palenicek
- Not yet recruiting
A-SHINE s.r.o.
Předměstí
Blanka Vopelková, +490 777 732 244, blanka.vopelkova@seznam.cz
Lubos Janu
Greece3 sites, 3 recruiting
- Recruiting
Eginitio Hospital
Athens, 11528
Adam Adamopoulos, +30 6976032181, adam_adamopoulos@yahoo.com
Nikos Stefanis
- Recruiting
Attikon University Hospital
Athens, 12462
Thomas Karantinos, +30697466610, tkarantinos@gmail.com
Nikolaos Smyrnis
- Recruiting
Papageorgiou General Hospital
Thessaloniki, 56404
Ogla Vampertzi, +306973852659, olgatrieste@hotmail.com
Georgios Papazisis
Ireland2 sites, 2 recruiting
- Recruiting
Sheaf House - Tallaght Adult Mental Health Service
Dublin, D24 WK80
Ann Connolly, +353 8616 79619, aconnolly@crp.healthcare
John Kelly
- Recruiting
La Nua Day Hospital Mental Health Centre
Galway, H91 VE03
Prathyusha Nedunuru, +353 874283750, pnedunuru@crp.healthcare
Shane McInerney
About this study
Official title: 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/
- Conditions
- Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders, Depression Disorder, Depression
- Being tested
- CYB003, Psychological Support
- Keywords
- MDD, Psychedelic, Depression, Major Depressive Disorder, CYB003, CYB003-001, CYB003-002, Psilocybin, psilocin-7438
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYB003Drug
CYB003 is a deuterated psilocin analog.
Psychological SupportBehavioural
Manualized psychological support performed by facilitator.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A CYB003 in 2 of 2 Dosing Sessions | Experimental | 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. Receives: Drug: CYB003; Behavioral: Psychological Support |
| Experimental Arm B CYB003 in 2 of 2 Dosing Sessions | Experimental | 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. Receives: Drug: CYB003; Behavioral: Psychological Support |
| Placebo Comparator: Arm C Placebo in 2 of 2 Dosing Session | Placebo comparator | 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. Receives: Behavioral: Psychological Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Scale (MADRS)
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.
Measured: Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.
Secondary outcomes (4)
The Beck Depression Inventory - Second Edition (BDI-II)
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.
Measured: Day -1, Day 21, Day 42 and Day 84/End of Trial.
The Clinical Global Impression Scale (CGI-S)
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:
- = Normal, not at all ill
- = Borderline ill
- = Mildly ill
- = Moderately ill
- = Markedly ill
- = Severely ill
- = Among the most extremely ill patients
Measured: Screening Day-45, Baseline Day -1, Day 42, Day 84/End of Trial.
The Generalized Anxiety Disorder 7-Item Scale (GAD-7)
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
Measured: 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)
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
Measured: Day -1, Day 21, Day 42 and Day 84/End of Trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start10 Dec 2025
- Primary completion7 Jun 2027 (estimated)
- Study completion9 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cybin IRL Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Felix Mazer, Study director, Cybin IRL Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793397
- Sponsor's protocol ID
- CYB003-003
- Acronym
- EMBRACE
- Status last verified
- Sep 2026
- First submitted
- 21 Jan 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No