Clinical trial 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder with a recent manic or mixed episode
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2006-01-16
Enrollment: 1169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
timeFrame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Secondary outcomes:
measure: Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2
timeFrame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)
timeFrame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)
timeFrame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs
timeFrame: Throughout Phase 2 (up to 52 weeks)
measure: Adjusted Mean Change From Baseline in Body Weight, Phase 2
timeFrame: Baseline, Week 52
measure: Number of Participants Showing Clinically Relevant Weight Loss by Study Week
timeFrame: Weeks 12, 24, 36, 52
measure: Number of Participants Showing Clinically Relevant Weight Gain by Study Week
timeFrame: Weeks 12, 24, 36, 52
measure: Adjusted Mean Change From Baseline in BMI by Study Week
timeFrame: Baseline, Weeks 12, 24, 36, 52
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment
timeFrame: Throughout the study, up to Week 52
measure: Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment
timeFrame: Up to 52 Weeks
measure: Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)
timeFrame: Throughout Phase 2 of the study, up to Week 52
measure: Summary of Concomitant Medications, Phase 1
timeFrame: Phase 1 (9 to 24 Week Single-blind Stabilization Phase)
measure: Summary of Concomitant Medications, Phase 2
timeFrame: Phase 2 (52 Week Double-blind Relapse Assessment Phase)
measure: Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
timeFrame: Baseline, Weeks 8, 24, 36, 52
measure: Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Baseline, Weeks 8, 24, 36, 52
measure: Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,
timeFrame: Baseline, Weeks 8, 24, 36, 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Tucson
country: United States
facility: Southwest Biomedical Research Foundation
state: Arizona
city: Anaheim
country: United States
facility: Pravin Kansagra, M.D.
state: California
city: Costa Mesa
country: United States
facility: College Hospital Costa Mesa
state: California
city: Los Angeles
country: United States
facility: Pacific Institute For Medical Research, Inc.
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Pasadena
country: United States
facility: Southern Ca Clinical Research, Inc.
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Boca Raton
country: United States
facility: Health Sciences America, Llc
state: Florida
city: Coral Springs
country: United States
facility: Cns Clinical Research Group
state: Florida
city: Daytona Beach
country: United States
facility: Act Clinical Research Institute, Llc
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center Of Southwest Florida
state: Florida
city: Miami
country: United States
facility: Aurora-Cuervo Clinical Trials
state: Florida
city: Port Charlotte
country: United States
facility: Gulf Coast Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center For Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Comprehensive Neuroscience, Inc
state: Georgia
city: Greenwood
country: United States
facility: Valle Vista Health System
state: Indiana
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc
state: Kansas
city: Wichita
country: United States
facility: Clinical Research Institute
state: Kansas
city: Lexington
country: United States
facility: University Of Kentucky, Dept. Of Psychiatry
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Behavioral Care
state: Kentucky
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Glen Burnie
country: United States
facility: Clinical Insights
state: Maryland
city: Rockville
country: United States
facility: Capital Clinical Research Associates
state: Maryland
city: Farmington Hills
country: United States
facility: Psychopharmacology Research Corporation
state: Michigan
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: St. Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Cherry Hill
country: United States
facility: University Of Medicine & Dentistry Of New Jersey
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo Psychiatric Center
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Zarzar Psychiatric Associates, Pllc
state: North Carolina
city: Bismarck
country: United States
facility: Horizon Medical Services
state: North Dakota
city: Canton
country: United States
facility: Neuro Behavioral Clinical Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cleveland
country: United States
facility: Saroj Brar Md, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: University Of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Center For Clinical Research
state: Pennsylvania
city: Dubois
country: United States
facility: Dubois Regional Medical Center
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Freimer, Martin
state: Pennsylvania
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center For Comprehensive Treatment
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cns Research Institute
state: Pennsylvania
city: Memphis
country: United States
facility: Ut Medical Group/Odyssey Research
state: Tennessee
city: Nashville
country: United States
facility: Psychiatric Consultants, Pc
state: Tennessee
city: Piney Flats
country: United States
facility: Harmony Research, Llc
state: Tennessee
city: Houston
country: United States
facility: Bayou City Research, Ltd.
state: Texas
city: San Antonio
country: United States
facility: Alamo Superior Research
state: Texas
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Virginia Beach
country: United States
facility: Windwood Centre
state: Virginia
city: Bothell
country: United States
facility: Pacific Institute Of Medical Sciences
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) Llc
state: Washington
city: Morgantown
country: United States
facility: Health Research Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Cabo Rojo
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Rio Piedras
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: