A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

This study has been completed.

First Received: October 18, 2004 Last Updated: June 27, 2008 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00094432

Purpose

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

Condition	Intervention	Phase
Bipolar I Disorder	Drug: Aripiprazole Drug: Placebo	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode. CN138-146 LT is the 26-Week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Mean change from baseline to endpoint on the MADRS total score.

Secondary Outcome Measures:

Clinical Global Impression - Bipolar Version
Severity of illness score depression
Mean change from baseline to endpoint

Estimated Enrollment:	650
Study Start Date:	June 2004

Arms	Assigned Interventions
A1: Active Comparator	Drug: Aripiprazole Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
A2: Placebo Comparator	Drug: Placebo Tablets, Oral, 0 mg, Once daily, 8 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, ages 18-65
Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094432

Show 47 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

Study ID Numbers:	CN138-146
Study First Received:	October 18, 2004
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00094432 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

depressed

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
Behavioral Symptoms

Additional relevant MeSH terms:

Disease
Depression
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