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

ConditionMajor Depressive Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BMS-986511

    Drug

    Specified dose on specified days

  • Placebo

    Drug

    Specified dose on specified days

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: BMS-986511: Dose AExperimental treatment 1 intervention
Group B: BMS-986511: Dose BExperimental treatment 1 intervention
Group C: PlaceboExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: