← Back to all trials
Not Yet Recruiting
NCT07772531
A Study to Evaluate BMS-986511 in Adults With Major Depressive Disorder
Conditions: Major Depressive Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 200
Sponsor: Bristol-Myers Squibb
Location: Local Institution - 0144 Phoenix Arizona
Summary
A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07772531). StuddyBuddy aggregates publicly available trial information.
