A Study to Evaluate BMS-986511 in Adults With Major Depressive Disorder

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

A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder

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 primary psychiatric disorders or a history of treatment-resistant depression during the current episode.
• Participants must not have recent history of active suicidal ideation or attempt within the past year.
• Participants must not have prior lifetime treatment with electroconvulsive therapy, ketamine/esketamine, deep brain stimulation, or transcranial magnetic stimulation.
• Participants must not have recent history of alcohol/substance abuse or use of cannabis.
• Participants must not have significant ECG abnormalities, or poorly controlled diabetes.
• Other protocol defined inclusion/exclusion criteria apply.