A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

Condition(s) targeted: Depressive Disorder, Major

Intervention: Lithium or Valproate with PBO (Drug); Lithium or Valproate with Aripiprazole (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

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Any mood episode

Secondary outcome: Mean change in the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (mania)

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

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.

Local Institution, Rio De Janeiro 21020, Brazil

Local Institution, Sao Paulo 05403, Brazil

Local Institution, Bourgas 8000, Bulgaria

Local Institution, Rousse 7002, Bulgaria

Local Institution, Zadar 23000, Croatia

Local Institution, Split 21000, Croatia

Local Institution, Zagreb 10 090, Croatia

Local Institution, Rijeka 51-000, Croatia

Local Institution, Litomerice 412 01, Czech Republic

Local Institution, Prerov 75002, Czech Republic

Local Institution, Prague 2 120 00, Czech Republic

Local Institution, Havirov 736 01, Czech Republic

Local Institution, Praha 6 160 00, Czech Republic

Local Institution, Brno 625 00, Czech Republic

Local Institution, Brno 610 00, Czech Republic

Local Institution, Rennes 35000, France

Local Institution, Henin Beaumont 62251, France

Local Institution, Nantes 44000, France

Local Institution, La Seyne Sur Mer 83500, France

Local Institution, Nimes 30900, France

Local Institution, Dole 39100, France

Local Institution, Marseille 13009, France

Local Institution, Jonzac Cedex 175003, France

Local Institution, Hyderabad 500 038, India

Local Institution, Delhi 110 092, India

Local Institution, Mumbai 400 008, India

Local Institution, Mumbai 400 058, India

Local Institution, New Delhi 110 002, India

Local Institution, New Delhi 110 065, India

Local Institution, St-Petersburg 190000, Russian Federation

Local Institution, Moscow 107258, Russian Federation

Local Institution, Izhevsk 426053, Russian Federation

Local Institution, Nizhny Novgorod 603107, Russian Federation

Local Institution, Saratov 410028, Russian Federation

Local Institution, Tomsk 634014, Russian Federation

Local Institution, Saint-Petersburg 191119, Russian Federation

Tuscaloosa Va Medical Center, Tuscaloosa, Alabama 35404, United States

Local Institution, Hyderabad, Andhra Pradesh 500 034, India

Local Institution, Salvador, Bahia 40325, Brazil

Synergy Clinical Research Center, National City, California 91950, United States

Va Long Beach Healthcare System, Long Beach, California 90822, United States

Atp Clinical Research, Inc., Costa Mesa, California 92626, United States

University Of California, Irvine Medical Center, Orange, California 92868, United States

Psychopharmacology Research Network Of Torrance, Cerritos, California 90703, United States

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

Us Clinical Research Centers, Llc, Costa Mesa, California 92627, United States

Local Institution, Nantes, Cedex 01 44035, France

University Of South Florida, Tampa, Florida 33613, United States

Clinical Neuroscience Solutions, Inc., Orlando, Florida 32806, United States

Local Institution, Pretoria, Gauteng 0001, South Africa

Carman Research, Smyrna, Georgia 30080, United States

Local Institution, Aparecida De Goi�nia, Goias 74922, Brazil

Local Institution, Ahmedabad, Gujarat 6577647, India

Local Institution, Ahmedabad, Gujarat 380 006, India

Local Institution, Berea, Kwa Zulu Natal 4001, South Africa

Local Institution, Durban, Kwa Zulu Natal 4001, South Africa

Local Institution, Pune, Maharashtra 400 001, India

Local Institution, Kalyan (West), Maharashtra 421 301, India

Local Institution, Nagur, Maharashtra 440010, India

Local Institution, Mangalore, Manipal 576 104, India

University Of Massachusetts Medical School, Worcester, Massachusetts 01605, United States

Psych Care Consultants Research, St. Louis, Missouri 63128, United States

Cns Research Institute, P.C., Clementon, New Jersey 08021, United States

Neuropsychiatric Research Associates, New York, New York 10128, United States

Behavioral Medical Research Of Staten Island, Staten Island, New York 10305, United States

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

Psychiatry And Clinical Research, Raleigh, North Carolina 27609, United States

Metro Health Medical Center, Cleveland, Ohio 44109, United States

University Of Cincinnati Medical Center, Cincinnati, Ohio 45267, United States

Rakesh Ranjan, Md & Associates, Inc., Beachwood, Ohio 44122, United States

Midwest Clinical Research Center, Dayton, Ohio 45408, United States

Portland Va Medical Center, Portland, Oregon 97201, United States

Local Institution, Pelotas, Rio Grande Do Sul 96030 003, Brazil

Local Institution, S�o Paulo, Sao Paulo 02340, Brazil

Local Institution, Mumbai, Sion (W) 400 022, India

Red Oak Psychiatry Associates, Pa, Houston, Texas 77090, United States

Senior Adults Specialty Research, Inc., Austin, Texas 78757, United States

Futuresearch Trials, Dallas, Texas 75231, United States

Insite Clinical Research, Desoto, Texas 75115, United States

University Of Utah School Of Medicine, Salt Lake City, Utah 84132, United States

Northwest Clinical Research Center, Bellevue, Washington 98004, United States

Local Institution, Paarl, Western Cape 7646, South Africa

Local Institution, Cape Town, Western Cape 7708, South Africa

BMS Clinical Trials Disclosure

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

Starting date: September 2005
Ending date: July 2009
Last updated: May 15, 2008