Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: Pexacerfont; Drug: Escitalopram; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00135421

CN148-007

Details and patient eligibility

About

The purpose of this clinical research study is to learn whether BMS-562086 is both safe and effective in treating outpatients with major depressive disorder.

Enrollment: 271 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient women meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for a single or recurrent, non-psychotic episode of Major Depressive Disorder (296.2x and 296.3x).
• Patients whose current depressive episode is at least three months in duration at the Baseline Visit.

Exclusion criteria

• Males
• Patients with treatment resistance to other antidepressants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

271 participants in 3 patient groups, including a placebo group

A1

Experimental group

Treatment:

Drug: Pexacerfont

A2

Active Comparator group

Treatment:

Drug: Escitalopram

A3

Placebo Comparator group

Treatment:

Drug: Placebo