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

NCT07772531

Not Yet RecruitingPhase 2

Sponsor: Bristol-Myers Squibb

Conditions: Major Depressive Disorder

Interventions: BMS-986511, Placebo

Countries: United States, Czechia

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (26)

Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Rogers, Arkansas, United States
Garden Grove, California, United States
Glendale, California, United States
Lemon Grove, California, United States
Oakland, California, United States
Upland, California, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Gaithersburg, Maryland, United States
Boston, Massachusetts, United States
Cedarhurst, New York, United States
Mount Kisco, New York, United States
Staten Island, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Dallas, Texas, United States
Everett, Washington, United States
Prague, Praha 6, Czechia
Prague, Praha 8, Czechia
Kladno, Czechia
Klecany, Czechia
Pilsen, Czechia
Prague, Czechia