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

PHASE4CompletedINTERVENTIONAL
Enrollment

1,169

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
Bipolar Disorder
Interventions
DRUG

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"

DRUG

Lamotrigine + Placebo

"Tablets, Oral, once daily, Phase 2 - up to 52 weeks~Lamotrigine 100-200 mg/day~placebo 0 mg/day"

Trial Locations (66)

10312

Richmond Behavioral Associates, Staten Island

14213

Buffalo Psychiatric Center, Buffalo

14618

Finger Lakes Clinical Research, Rochester

15801

Dubois Regional Medical Center, DuBois

18103

Lehigh Valley Hospital, Allentown

18104

Lehigh Center For Clinical Research, Allentown

18301

Freimer, Martin, East Stroudsburg

19104

University Of Pennsylvania, Philadelphia

19131

Belmont Center For Comprehensive Treatment, Philadelphia

19149

Cns Research Institute, Philadelphia

20852

Capital Clinical Research Associates, Rockville

21061

Clinical Insights, Glen Burnie

21285

Sheppard Pratt Health System, Baltimore

22903

University Of Virginia Health System, Charlottesville

23452

Windwood Centre, Virginia Beach

26506

Health Research Center, Morgantown

27607

Zarzar Psychiatric Associates, Pllc, Raleigh

27705

Duke University Medical Center, Durham

30328

Comprehensive Neuroscience, Inc, Atlanta

32124

Act Clinical Research Institute, Llc, Daytona Beach

33065

Cns Clinical Research Group, Coral Springs

33143

Aurora-Cuervo Clinical Trials, Miami

33407

Janus Center For Psychiatric Research, West Palm Beach

33432

Health Sciences America, Llc, Boca Raton

33912

Neuropsychiatric Research Center Of Southwest Florida, Fort Myers

33952

Gulf Coast Medical Research, Port Charlotte

35205

University Of Alabama At Birmingham, Birmingham

37203

Psychiatric Consultants, Pc, Nashville

37686

Harmony Research, Llc, Piney Flats

38105

Ut Medical Group/Odyssey Research, Memphis

39232

Precise Research Centers, Flowood

40509

University Of Kentucky, Dept. Of Psychiatry, Lexington

42301

Owensboro Behavioral Care, Owensboro

44113

Saroj Brar Md, Inc, Cleveland

44708

Neuro Behavioral Clinical Research, Inc., Canton

45227

Community Research, Cincinnati

46143

Valle Vista Health System, Greenwood

47802

Clinco, Terre Haute

48334

Psychopharmacology Research Corporation, Farmington Hills

53233

Aurora Health Care, Milwaukee

55101

Regions Hospital, Saint Paul

55455

University Of Minnesota, Minneapolis

58501

Horizon Medical Services, Bismarck

66206

Clinical Trials Technology, Inc, Prairie Village

67213

Clinical Research Institute, Wichita

73104

University Of Oklahoma Health Sciences Center, Oklahoma City

73116

Cutting Edge Research, Oklahoma City

77007

Bayou City Research, Ltd., Houston

78229

Alamo Superior Research, San Antonio

85712

Southwest Biomedical Research Foundation, Tucson

90024

Pacific Institute For Medical Research, Inc., Los Angeles

90502

Los Angeles Biomedical Research Institute, Torrance

91106

Southern Ca Clinical Research, Inc., Pasadena

91786

Pacific Clinical Research Medical Group, Upland

92056

Excell Research, Oceanside

92627

College Hospital Costa Mesa, Costa Mesa

92801

Pravin Kansagra, M.D., Anaheim

94305

Stanford University, Stanford

97210

Summit Research Network, Portland

98011

Pacific Institute Of Medical Sciences, Bothell

98104

Summit Research Network (Seattle) Llc, Seattle

08002

University Of Medicine & Dentistry Of New Jersey, Cherry Hill

00623

Local Institution, Cabo Rojo

00731

Local Institution, Ponce

00926

Local Institution, Rio Piedras

00918

Local Institution, San Juan

Sponsors
All Listed Sponsors
collaborator

Otsuka America Pharmaceutical

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT00277212 - 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 | Biotech Hunter | Biotech Hunter