Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, Depression, BMS-986511, Evifacotrep, TRPC4/5 Inhibitor, Antidepressant, Mood Disorders, Central Nervous System, MDD
Brief summary
A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder
Interventions
DRUGBMS-986511
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score | Up to Day 57 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events (AEs) | Up to 71 days |
| Number of Participants with Serious Adverse Events (SAEs) | Up to 71 days |
| Number of Participants with AEs Leading to Treatment Discontinuation | Up to 71 days |
| Number of Participants with AEs Leading to Death | Up to Day 71 |
Countries
Czechia, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed