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Completed

NCT Number: NCT00135421

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Apc Clinical Research Trials Nw, Pa, Springdale, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pexacerfont

Drug

Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation

Other names: BMS-562086

Escitalopram

Drug

Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.

Placebo

Drug

Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.

Primary outcomes

  1. Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)

    Time frame: Week 8

Secondary outcomes

  1. Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests

    Time frame: every visit and endpoint

  2. Compare efficacy of escitalopram to placebo

    Time frame: at endpoint and at each visit

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 26, 2005
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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