An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder
Cybin IRL Limited
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
- 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: * Age18 to 85 years. * 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. * Moderate to severe depression at Screening and Baseline, independently confirmed. * Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prio…
Interventions
- DrugCYB003
CYB003 is a deuterated psilocin analog.
- BehavioralPsychological Support
Manualized psychological support performed by facilitator.
Locations (67)
- UAB Psychiatry and Behavioral NeurologyBirmingham, Alabama
- Lighthouse PsychiatryGilbert, Arizona
- Pillar Clinical Research - Little RockLittle Rock, Arkansas
- Behavioral Research Specialists, LLCGlendale, California
- Sun Valley Research CenterImperial, California
- CalNeuro Research GroupLos Angeles, California