"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCybin IRL Limited
About this trial
The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 85 years inclusive, at Screening
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.
Depression is of moderate to severe degree at Screening and Baseline, independently confirmed by additional clinical assessments
Participant has been on a stable dose of a single antidepressant medication at an adequate dose (label specified) for an adequate duration in the last month prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CYB003
DrugCYB003 is a Deuterated Psilocin Analog.
Psychological Support
BehavioralManualized psychological support performed by facilitators
Placebo
DrugPlacebo
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Experimental Arm A: CYB003 in 2 of 2 Dosing SessionsExperimental treatment 2 interventions
Group B: Placebo Comparator Arm B: Placebo in 2 of 2 Dosing SessionsPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity.
Time frame
Screening Day-45, Baseline Day-1, Day 2, Day 10, Day 21, Day 23, Day 31, and Day 42 (End of Treatment)Secondary outcomes
1
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.
Time frame
Baseline Day-1, Day 21, and Day 42 (End of Treatment)2
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 and global improvement measures will be utilized for this trial.
Time frame
Screening Day-45, Baseline Day-1, and Day 42 (End of Treatment)3
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.
Time frame
Baseline Day-1, Day 21, and Day 42 (End of Treatment)4
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 into 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.
Time frame
Baseline Day-1, Day 21, and Day 42 (End of Treatment)Sponsors and contacts
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Source ClinicalTrials.gov