ClinicalTrials.gov record
Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT00277212

Public ClinicalTrials.gov record NCT00277212. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 11:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT00277212
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
1,169 participants

Conditions and interventions

Interventions

  • Lamotrigine + Aripiprazole Drug
  • Lamotrigine + Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2005
Primary completion
Jun 30, 2009
Completion
Jun 30, 2009
Last update posted
May 12, 2026

2005 – 2009

United States locations

U.S. sites
62
U.S. states
26
U.S. cities
58
Facility City State ZIP Site status
University Of Alabama At Birmingham Birmingham Alabama 35205
Southwest Biomedical Research Foundation Tucson Arizona 85712
Pravin Kansagra, M.D. Anaheim California 92801
College Hospital Costa Mesa Costa Mesa California 92627
Pacific Institute For Medical Research, Inc. Los Angeles California 90024
Excell Research Oceanside California 92056
Southern Ca Clinical Research, Inc. Pasadena California 91106
Stanford University Stanford California 94305
Los Angeles Biomedical Research Institute Torrance California 90502
Pacific Clinical Research Medical Group Upland California 91786
Health Sciences America, Llc Boca Raton Florida 33432
Cns Clinical Research Group Coral Springs Florida 33065
Act Clinical Research Institute, Llc Daytona Beach Florida 32124
Neuropsychiatric Research Center Of Southwest Florida Fort Myers Florida 33912
Aurora-Cuervo Clinical Trials Miami Florida 33143
Gulf Coast Medical Research Port Charlotte Florida 33952
Janus Center For Psychiatric Research West Palm Beach Florida 33407
Comprehensive Neuroscience, Inc Atlanta Georgia 30328
Valle Vista Health System Greenwood Indiana 46143
Clinco Terre Haute Indiana 47802
Clinical Trials Technology, Inc Prairie Village Kansas 66206
Clinical Research Institute Wichita Kansas 67213
University Of Kentucky, Dept. Of Psychiatry Lexington Kentucky 40509
Owensboro Behavioral Care Owensboro Kentucky 42301
Sheppard Pratt Health System Baltimore Maryland 21285
Clinical Insights Glen Burnie Maryland 21061
Capital Clinical Research Associates Rockville Maryland 20852
Psychopharmacology Research Corporation Farmington Hills Michigan 48334
University Of Minnesota Minneapolis Minnesota 55455
Regions Hospital Saint Paul Minnesota 55101
Precise Research Centers Flowood Mississippi 39232
University Of Medicine & Dentistry Of New Jersey Cherry Hill New Jersey 08002
Buffalo Psychiatric Center Buffalo New York 14213
Finger Lakes Clinical Research Rochester New York 14618
Richmond Behavioral Associates Staten Island New York 10312
Duke University Medical Center Durham North Carolina 27705
Zarzar Psychiatric Associates, Pllc Raleigh North Carolina 27607
Horizon Medical Services Bismarck North Dakota 58501
Neuro Behavioral Clinical Research, Inc. Canton Ohio 44708
Community Research Cincinnati Ohio 45227
Saroj Brar Md, Inc Cleveland Ohio 44113
University Of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104
Cutting Edge Research Oklahoma City Oklahoma 73116
Summit Research Network Portland Oregon 97210
Lehigh Valley Hospital Allentown Pennsylvania 18103
Lehigh Center For Clinical Research Allentown Pennsylvania 18104
Dubois Regional Medical Center DuBois Pennsylvania 15801
Freimer, Martin East Stroudsburg Pennsylvania 18301
University Of Pennsylvania Philadelphia Pennsylvania 19104
Belmont Center For Comprehensive Treatment Philadelphia Pennsylvania 19131
Cns Research Institute Philadelphia Pennsylvania 19149
Ut Medical Group/Odyssey Research Memphis Tennessee 38105
Psychiatric Consultants, Pc Nashville Tennessee 37203
Harmony Research, Llc Piney Flats Tennessee 37686
Bayou City Research, Ltd. Houston Texas 77007
Alamo Superior Research San Antonio Texas 78229
University Of Virginia Health System Charlottesville Virginia 22903
Windwood Centre Virginia Beach Virginia 23452
Pacific Institute Of Medical Sciences Bothell Washington 98011
Summit Research Network (Seattle) Llc Seattle Washington 98104
Health Research Center Morgantown West Virginia 26506
Aurora Health Care Milwaukee Wisconsin 53233

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00277212, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 12, 2026 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00277212 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →