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Not yet recruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BMS-986511 in adults with major depressive disorder, also called depression. It is for people whose current depression is moderate to severe and has lasted more than 12 weeks.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have depression confirmed by a structured interview using standard diagnosis rules.
  • Have current moderate to severe depression confirmed by a clinical exam and a rating scale.
  • Have a current period of depression lasting more than 12 weeks at screening.
  • Receive care without staying in a hospital and be able to follow study steps.
  • Finish the required time off certain medicines before the study's starting visit.
  • Have a body mass index (BMI), a measure based on height and weight, within the study's allowed range.
  • Meet the study's safety rules related to pregnancy and reproduction.

Who can't join

  • Have another main mental health condition, or depression that has resisted treatment during the current period of depression.
  • Have had active thoughts of suicide or a suicide attempt within the past year.
  • Have ever received electroconvulsive therapy (electrical treatment for the brain), ketamine or esketamine, deep brain stimulation (treatment using implanted electrodes), or transcranial magnetic stimulation (magnetic treatment for the brain).
  • Have a recent history of alcohol or drug abuse, or cannabis use.
  • Have major problems on an ECG (a test of the heart's electrical activity), or diabetes that is not well controlled.
  • Other study rules may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (21)

AR

AZ

CA

FL

GA

MA

MD

NY

OH

OK

TX

WA