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
NCT ID: NCT00277212
Last Updated: 2013-12-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1169 participants
INTERVENTIONAL
2005-12-31
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A1
Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole
Lamotrigine + Aripiprazole
Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
Aripiprazole 10-30 mg/day
A2
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo
Lamotrigine + Placebo
Tablets, Oral, once daily, Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
placebo 0 mg/day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lamotrigine + Aripiprazole
Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
Aripiprazole 10-30 mg/day
Lamotrigine + Placebo
Tablets, Oral, once daily, Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
placebo 0 mg/day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka America Pharmaceutical
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bristol-Myers Squibb
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Of Alabama At Birmingham
Birmingham, Alabama, United States
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
Clinical Insights
Glen Burnie, Maryland, United States
Capital Clinical Research Associates
Rockville, Maryland, United States
Psychopharmacology Research Corporation
Farmington Hills, Michigan, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Precise Research Centers
Flowood, Mississippi, United States
University Of Medicine & Dentistry Of New Jersey
Cherry Hill, New Jersey, United States
Buffalo Psychiatric Center
Buffalo, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Zarzar Psychiatric Associates, Pllc
Raleigh, North Carolina, United States
Horizon Medical Services
Bismarck, North Dakota, United States
Neuro Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Saroj Brar Md, Inc
Cleveland, Ohio, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Cutting Edge Research
Oklahoma City, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, United States
Dubois Regional Medical Center
DuBois, Pennsylvania, United States
Freimer, Martin
East Stroudsburg, Pennsylvania, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, United States
Cns Research Institute
Philadelphia, Pennsylvania, United States
Ut Medical Group/Odyssey Research
Memphis, Tennessee, United States
Psychiatric Consultants, Pc
Nashville, Tennessee, United States
Harmony Research, Llc
Piney Flats, Tennessee, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Alamo Superior Research
San Antonio, Texas, United States
University Of Virginia Health System
Charlottesville, Virginia, United States
Windwood Centre
Virginia Beach, Virginia, United States
Pacific Institute Of Medical Sciences
Bothell, Washington, United States
Summit Research Network (Seattle) Llc
Seattle, Washington, United States
Health Research Center
Morgantown, West Virginia, United States
Aurora Health Care
Milwaukee, Wisconsin, United States
Local Institution
Cabo Rojo, , Puerto Rico
Local Institution
Ponce, , Puerto Rico
Local Institution
Rio Piedras, , Puerto Rico
Local Institution
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CN138-392 ST
Identifier Type: -
Identifier Source: org_study_id