A Study of Aripiprazole in Patients With Major Depressive Disorder

This study has been completed.

First Received: March 9, 2005 Last Updated: October 14, 2008 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00105196

Purpose

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Aripiprazole+ ADT Drug: Placebo+ ADT	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of Aripiprazole in Patients With Major Depressive Disorder

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change in a depression rating scale [ Time Frame: at endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in a disability scale and Clinical Global Impression scale [ Time Frame: at endpoint ] [ Designated as safety issue: No ]

Enrollment:	349
Study Start Date:	March 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: Aripiprazole+ ADT Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
A2: Placebo Comparator	Drug: Placebo+ ADT Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration.
Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105196

Show 34 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional 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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN138-165
Study First Received:	March 9, 2005
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00105196 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Single or recurrent
non-psychotic episode of Major Depressive Disorder

Study placed in the following topic categories:

Tranquilizing Agents
Depression
Mental Disorders
Psychotropic Drugs
Mood Disorders
Central Nervous System Depressants

Aripiprazole
Depressive Disorder, Major
Antipsychotic Agents
Depressive Disorder
Recurrence
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Aripiprazole
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009