Study to Evaluate the Efficacy and Safety of Aripiprazole in Combination With Lithium or Valproate Over 12 Weeks in the Treatment of Patients Diagnosed With Bipolar I Disorder Mania

This study is currently recruiting participants.

Verified by Bristol-Myers Squibb, January 2009

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00665366

Purpose

The purpose of the study is to determine if aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks

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

MedlinePlus related topics: Bipolar Disorder

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Mean change in the YMRS Total score [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in the CGI-BP Severity of Illness, PGI-I, FAST & LIFE-RIFT scores, vital signs, labs, ECGs & physical measurements (height, weight) [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	388
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator	Drug: Aripiprazole 5 mg, 10 mg or 15 mg oral tablets and administered at starting dose of 5 mg/day for Week 1, uptitrated to 10 mg/day for Weeks 2 and 3, 15 mg/day for Weeks 4, 5 and 6 and then flexible dose of either 15 or 30 mg/day for Weeks 7 to 12, once daily, 12 weeks
A2: Placebo Comparator	Drug: Placebo Tablets, Oral, 0 mg, once daily, 12 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Clinical diagnosis of Bipolar I mania (YMRS≥16)
Treated with lithium or valproate monotherapy for a manic episode and based on the investigator's clinical judgment could benefit from adjunctive treatment with aripiprazole

Exclusion Criteria:

Subject with a diagnosis of delirium, dementia, amnestic or other cognitive disorders, or a psychotic disorder
Subject with a current diagnosis of Bipolar II Disorder, Bipolar Disorder NOS, or any other primary psychiatric disorder other than Bipolar I Disorder
Subject with thyroid pathology
Subjects demonstrating cocaine abuse or dependence within the past 3 months prior to screening
Subject with a history of neuroleptic malignant syndrome from antipsychotic agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665366

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 99 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

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: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN138-502, EudraCT number 2007-005959-42
Study First Received:	April 18, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00665366
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Lithium Carbonate

Psychotic Disorders
Aripiprazole
Valproic Acid
Lithium

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009