"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
Qualifiers
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
Treatments tested in this trial
- CYB003
- Psychological Support
- Placebo
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov