Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07772531

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

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0080, Prague, Czech Republic, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986511

Drug

Specified dose on specified days

Other names: Evifacotrep

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score

    Time frame: Up to Day 57

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (AEs)

    Time frame: Up to 71 days

  2. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to 71 days

  3. Number of Participants with AEs Leading to Treatment Discontinuation

    Time frame: Up to 71 days

  4. Number of Participants with AEs Leading to Death

    Time frame: Up to Day 71

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.