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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00135421
First received: August 25, 2005
Last updated: February 27, 2010
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Pexacerfont
Drug: Escitalopram
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Compare efficacy of escitalopram to placebo [ Time Frame: at endpoint and at each visit ] [ Designated as safety issue: No ]

Enrollment: 271
Study Start Date: November 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Pexacerfont
Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation
Other Name: BMS-562086
Active Comparator: A2 Drug: Escitalopram
Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
Placebo Comparator: A3 Drug: Placebo
Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135421

  Show 45 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00135421     History of Changes
Other Study ID Numbers: CN148-007
Study First Received: August 25, 2005
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014