RecruitingMajor Depressive Disorder

"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"

Eligible age

18–85 yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: Cybin IRL Limited

You may qualify if…

✓ Participants must meet all the following criteria to be included in the trial:
✓ 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.
✓ Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤ 40 kg/m2), inclusive, at Screening.
✓ Participant is able to refrain from nicotine use during the dosing session (up to 8 hours)
✓ Registered with a healthcare professional who can confirm the diagnosis and previous treatments received by the participant.

You may not qualify if…

✕ 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.
✕ 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 antidepressant, mirtazapine, trazodone, moclobemide, buspirone, ketamine or S-ketamine, or an antipsychotic or mood stabilizer for MDD. Note: if receiving these medications for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1.