A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder
Cybin IRL Limited
Summary
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
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 antidepre…
Interventions
- DrugCYB003
CYB003 is a Deuterated Psilocin Analog.
- BehavioralPsychological Support
Manualized psychological support performed by facilitators
- DrugPlacebo
Placebo
Locations (46)
- Scottsdale Research InstitutePhoenix, Arizona
- Mountain Clinical TrialsPhoenix, Arizona
- Noble Clinical ResearchTucson, Arizona
- Del Sol Research ManagementTucson, Arizona
- CenExel CIT (Clinical Innovations, Inc)Bellflower, California
- Kadima Neuropsychiatry InstituteLa Jolla, California