A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00261443

Purpose

The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Lithium or Valproate with PBO Drug: Lithium or Valproate with Aripiprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproic acid Aripiprazole Lithium carbonate Lithium citrate Valproate Sodium

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Any mood episode [ Time Frame: The time from randomization to relapse ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (mania) [ Time Frame: from baseline (end of Phase 2) to endpoint (Week 52 LOCF) ] [ Designated as safety issue: No ]

Estimated Enrollment:	1300
Study Start Date:	September 2005
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Placebo Comparator /Active Comparator	Drug: Lithium or Valproate with PBO Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily
A2: Experimental	Drug: Lithium or Valproate with Aripiprazole Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks) lithium 250-2100 mg/day valproate 250-2500mg/day aripiprazole 15-30 mg/day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women > or = to 18 years of age meeting Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, currently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes or sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261443

Show 83 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:	CN138-189
Study First Received:	December 1, 2005
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00261443 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Bipolar I Disorder with a recent manic or mixed episode

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Valproic Acid
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Aripiprazole
Lithium
Antidepressive Agents
Tranquilizing Agents

Disease
Bipolar Disorder
Central Nervous System Depressants
Lithium Carbonate
Enzyme Inhibitors
Antimanic Agents
Antipsychotic Agents
Pharmacologic Actions
Mood Disorders
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010