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Clinical Trials in Czechia / NCT07772531
Starting soon Phase 2

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

NCT07772531 · tracked via the Priya Life Science Czechia tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2
Started
2026-10-30
Last updated
2026-09-04

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

BMS-986511Placebo

BMS-986511: Specified dose on specified days

Placebo: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score — Up to Day 57

Trial sites (27)

FacilityCityRegionStatus
Local Institution - 0144 Phoenix Arizona
Local Institution - 0038 Little Rock Arkansas
Local Institution - 0047 Rogers Arkansas
Local Institution - 0046 Garden Grove California
Local Institution - 0042 Glendale California
Local Institution - 0071 Lemon Grove California
Local Institution - 0079 Oakland California
Local Institution - 0050 Upland California
Local Institution - 0007 Jacksonville Florida
Local Institution - 0024 Orlando Florida
Local Institution - 0140 Atlanta Georgia
Local Institution - 0044 Gaithersburg Maryland
Local Institution - 0075 Boston Massachusetts
Local Institution - 0041 Cedarhurst New York
Local Institution - 0069 Mount Kisco New York
Local Institution - 0121 Staten Island New York
Local Institution - 0083 Cincinnati Ohio
Local Institution - 0086 Columbus Ohio
Local Institution - 0027 Oklahoma City Oklahoma
Local Institution - 0016 Dallas Texas
Local Institution - 0003 Everett Washington
Local Institution - 0080 Prague Czech Republic
Local Institution - 0111 Prague Praha 6
Local Institution - 0032 Prague Praha 8
Local Institution - 0005 Kladno Czechia
Local Institution - 0081 Klecany Czechia
Local Institution - 0028 Pilsen Czechia

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Other trials for the same condition

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07772531 on ClinicalTrials.gov ↗ ← All trials in Czechia