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

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 I Phase II

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

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
A1: Experimental	Drug: Pexacerfont Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation
A2: Active Comparator	Drug: Escitalopram Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
A3: Placebo Comparator	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

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

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN148-007
First Received:	August 25, 2005
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00135421
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Dexetimide

Depressive Disorder

Citalopram

Serotonin

Behavioral Symptoms

Additional relevant MeSH terms:

Parasympatholytics

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists

Anti-Dyskinesia Agents

Physiological Effects of Drugs

Psychotropic Drugs

Antiparkinson Agents

Cholinergic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Muscarinic Antagonists

Serotonin Agents

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135421