Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01369095

Enrollment

976

Registered

2011-06-08

Start date

2011-07-31

Completion date

2013-05-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

Interventions

DRUGDuloxetine

Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D)

DRUGEscitalopram

Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D)

DRUGBMS-820836 Placebo

Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)

DRUGBMS-820836

Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Men and women of age 18-65 years (Argentina minimum age will be 24 years of age) * Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use. * Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (Text Revision)\[DSM IV TR\] criteria. The current depressive episode must be \> 8 weeks in duration and \< 3 years duration. * In the current Major depressive disorder (MDD) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment. * Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at Screening and Baseline.

Exclusion criteria

* Patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode. * Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.

Design outcomes

Primary

Measure	Time frame
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score	Week 13

Secondary

Measure	Time frame
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.	Week 13

Countries

Argentina, Australia, Austria, Canada, France, India, Italy, Puerto Rico, South Africa, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026