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/
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.
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.
Parallel
CYB003
DrugCYB003 is a deuterated psilocin analog.
Psychological Support
BehavioralManualized psychological support performed by facilitator.
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.
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.
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: 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
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
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
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Cybin IRL Limited
Lead sponsor
Worldwide Clinical Trials
Collaborator