A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Trial Parameters
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.
Eligibility Criteria
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 salp