A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

Condition(s) targeted: Bipolar Disorder

Intervention: Lamotrigine + Aripiprazole (Drug); Lamotrigine + Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode

Official title: A Multicenter, Double-Blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy measure will be the time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase (Phase 2)

Secondary outcome:

Time to any relapse (manic, mixed, depressive) in the Double-blind Relapse Assessment Phase

Time to Depressive relapse, in the Double-blind Relapse Assessment Phase

Time to discontinuation for any reason in the Double-blind Relapse Assessment Phase

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental

Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic

Exclusion Criteria:

- First manic episode

- Current manic or mixed episode with > 2 years duration

- Treated with aripiprazole within the past 3 months

- Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine

Local Institution, San Juan 00918, Puerto Rico

Local Institution, Ponce 00731, Puerto Rico

Local Institution, Cabo Rojo 00623, Puerto Rico

Pacific Clinical Research Medical Group, Upland, California 91786, United States

Pravin Kansagra, M.D., Anaheim, California 92801, United States

Pacific Institute For Medical Research, Inc., Los Angeles, California 90024, United States

Southern Ca Clinical Research, Inc., Pasadena, California 91106, United States

College Hospital Costa Mesa, Costa Mesa, California 92627, United States

Health Sciences America, Llc, Boca Raton, Florida 33432, United States

Neuropsychiatric Research Center Of Southwest Florida, Fort Myers, Florida 33912, United States

Janus Center For Psychiatric Research, West Palm Beach, Florida 33407, United States

Cns Clinical Research Group, Coral Springs, Florida 33065, United States

Comprehensive Neuroscience, Inc, Atlanta, Georgia 30328, United States

Clinco, Terre Haute, Indiana 47802, United States

Valle Vista Health System, Greenwood, Indiana 46143, United States

Clinical Trials Technology, Inc, Prarie Village, Kansas 66206, United States

Owensboro Behavioral Care, Owensboro, Kentucky 42301, United States

Capital Clinical Research Associates, Rockville, Maryland 20852, United States

Clinical Insights, Glen Burnie, Maryland 21061, United States

Sheppard Pratt Health System, Baltimore, Maryland 21285, United States

Regions Hospital, St. Paul, Minnesota 55101, United States

Precise Research Centers, Flowood, Mississippi 39232, United States

Finger Lakes Clinical Research, Rochester, New York 14618, United States

Richmond Behavioral Associates, Staten Island, New York 10312, United States

Glenwood Psychiatric Associates, Raleigh, North Carolina 27609, United States

Duke Univeristy Medical Center, Durham, North Carolina 27705, United States

Community Research, Cincinnati, Ohio 45227, United States

Saroj Brar Md, Inc, Cleveland, Ohio 44113, United States

Cutting Edge Research, Oklahoma City, Oklahoma 73116, United States

University Of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Summit Research Network, Portland, Oregon 97210, United States

Freimer, Martin, East Stroudsburg, Pennsylvania 18301, United States

Lehigh Center For Clinical Research, Allentown, Pennsylvania 18104, United States

University Of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Lehigh Valley Hospital, Allentown, Pennsylvania 18103, United States

Belmont Center For Comprehensive Treatment, Philadelphia, Pennsylvania 19131, United States

Psychiatric Consultants, Pc, Nashville, Tennessee 37203, United States

Ut Medical Group/Odyssey Research, Memphis, Tennessee 38105, United States

Bayou City Research, Ltd., Houston, Texas 77007, United States

Alamo Superior Research, San Antonio, Texas 78229, United States

Brighton Research Group, Virginia Beach, Virginia 23452, United States

Pacific Institute Of Medical Sciences, Bothell, Washington 98011, United States

Aurora Health Care, Milwaukee, Wisconsin 53233, United States

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2005
Ending date: July 2009
Last updated: June 10, 2008