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

Completed · Phase 4 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00277212

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

1169

Starts

2005-12-01

Expected to finish

2009-07-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southwest Biomedical Research Foundation — Tucson, Arizona, United States
• Pravin Kansagra, M.D. — Anaheim, California, United States
• College Hospital Costa Mesa — Costa Mesa, California, United States
• Pacific Institute For Medical Research, Inc. — Los Angeles, California, United States
• Excell Research — Oceanside, California, United States
• Southern Ca Clinical Research, Inc. — Pasadena, California, United States
• Stanford University — Stanford, California, United States
• Los Angeles Biomedical Research Institute — Torrance, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Health Sciences America, Llc — Boca Raton, Florida, United States
• Cns Clinical Research Group — Coral Springs, Florida, United States
• Act Clinical Research Institute, Llc — Daytona Beach, Florida, United States
• Neuropsychiatric Research Center Of Southwest Florida — Fort Myers, Florida, United States
• Aurora-Cuervo Clinical Trials — Miami, Florida, United States
• Gulf Coast Medical Research — Port Charlotte, Florida, United States
• Janus Center For Psychiatric Research — West Palm Beach, Florida, United States
• Comprehensive Neuroscience, Inc — Atlanta, Georgia, United States
• Valle Vista Health System — Greenwood, Indiana, United States
• Clinco — Terre Haute, Indiana, United States
• Clinical Trials Technology, Inc — Prairie Village, Kansas, United States
• Clinical Research Institute — Wichita, Kansas, United States
• University Of Kentucky, Dept. Of Psychiatry — Lexington, Kentucky, United States
• Owensboro Behavioral Care — Owensboro, Kentucky, United States
• Sheppard Pratt Health System — Baltimore, Maryland, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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