A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of BMS-986511 in Two Sequential Parts in Participants With Major Depressive Disorder
Bristol-Myers Squibb
Summary
A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must meet the MDD diagnosis per DSM-5 criteria confirmed by structured interview. * Participant must have current moderate to severe MDE confirmed by clinical assessment and validated scale. * Participant must have current MDE duration \>12 weeks at screening. * Outpatient participants able to comply with study procedures. * Participant require medication washout completed before baseline. * Participant must have BMI within protocol range. * Participants must meet reproductive safety requirements. Exclusion Criteria: * Participants must not have other prim…