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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06793397
Registration number
NCT06793397
Ethics application status
Date submitted
21/01/2025
Date registered
27/01/2025
Date last updated
8/09/2025
Titles & IDs
Public title
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
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Scientific 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
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Secondary ID [1]
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CYB003-003
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Universal Trial Number (UTN)
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Trial acronym
EMBRACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder (MDD)
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Depression in Adults
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Depression - Major Depressive Disorder
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Depression Disorders
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Depression Disorder
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Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CYB003
BEHAVIORAL - Psychological Support
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.
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.
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.
Treatment: Drugs: CYB003
CYB003 is a deuterated psilocin analog.
BEHAVIORAL: Psychological Support
Manualized psychological support performed by facilitator.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Montgomery-Asberg Depression Scale (MADRS)
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Assessment method [1]
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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.
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Timepoint [1]
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Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.
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Secondary outcome [1]
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The Beck Depression Inventory - Second Edition (BDI-II)
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Assessment method [1]
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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.
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Timepoint [1]
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Day -1, Day 21, Day 42 and Day 84/End of Trial.
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Secondary outcome [2]
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The Clinical Global Impression Scale (CGI-S)
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Assessment method [2]
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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
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Timepoint [2]
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Screening Day-45, Baseline Day -1, Day 42, Day 84/End of Trial.
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Secondary outcome [3]
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The Generalized Anxiety Disorder 7-Item Scale (GAD-7)
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Assessment method [3]
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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
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Timepoint [3]
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Baseline Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.
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Secondary outcome [4]
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The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
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Assessment method [4]
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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
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Timepoint [4]
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Day -1, Day 21, Day 42 and Day 84/End of Trial.
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Eligibility
Key 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.
* Moderate to severe depression at Screening.
* Participants have been on a stable dose of antidepressant medication at an adequate dose in the last 4 weeks prior to Screening.
* Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI =40 kg/m2), inclusive, at Screening.
* Participants with well controlled hypertension.
* Participant is able to refrain from smoking during the dosing session.
* Participants must use a condom plus spermicide during the trial and for 12 weeks afterwards.
Participants of childbearing potential must agree to use a highly effective method of and 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.
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Minimum age
18
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).
* Significant suicide risk within 12 months of Screening.
* Current or previous diagnosis of treatment-resistant MDD.
* 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.
* 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 hydroxytryptophan or St John's Wort within prior to trial medication administration.
* Strenuous exercise prior to each clinic visit.
* 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
8/10/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/05/2027
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Actual
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Sample size
Target
330
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Thompson Brain & Mind Healthcare (TBMH) - Maroochydore
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Recruitment hospital [3]
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Ramsay Clinic - Melbourne
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Recruitment hospital [4]
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Neurocentrix Research - Melbourne
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Recruitment hospital [5]
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Monash University - Notting Hill - Notting Hill
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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3053 - Melbourne
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Recruitment postcode(s) [5]
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3168 - Notting Hill
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arkansas
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California
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United States of America
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Connecticut
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Florida
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Georgia
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Illinois
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Louisiana
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New Jersey
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New York
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Oklahoma
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Pennsylvania
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Texas
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Washington
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Greece
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Athens
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Greece
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Thessaloniki
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Ireland
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Dublin
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Ireland
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Galway
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United Kingdom
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Berkshire
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United Kingdom
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Doncaster
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cybin IRL Limited
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Worldwide Clinical Trials
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06793397
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Felix Mazer
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Address
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Cybin IRL Limited
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Clinical Development
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Address
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Phone
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1-866-292-4601 x799
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06793397
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