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
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
1 other identifier
interventional
1,169
2 countries
66
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2005
Longer than P75 for phase_4
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 13, 2006
CompletedFirst Posted
Study publicly available on registry
January 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
October 20, 2010
CompletedMay 13, 2026
April 1, 2026
3.6 years
January 13, 2006
September 20, 2010
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Secondary Outcomes (16)
Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2
Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)
Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)
Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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
Throughout Phase 2 (up to 52 weeks)
Adjusted Mean Change From Baseline in Body Weight, Phase 2
Baseline, Week 52
- +11 more secondary outcomes
Study Arms (2)
A1
EXPERIMENTALPhase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole
A2
PLACEBO COMPARATORPhase 2 Double-Blind Treatment: Lamotrigine + Placebo
Interventions
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
Tablets, Oral, once daily, Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day placebo 0 mg/day
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
University Of Alabama At Birmingham
Birmingham, Alabama, 35205, United States
Southwest Biomedical Research Foundation
Tucson, Arizona, 85712, United States
Pravin Kansagra, M.D.
Anaheim, California, 92801, United States
College Hospital Costa Mesa
Costa Mesa, California, 92627, United States
Pacific Institute For Medical Research, Inc.
Los Angeles, California, 90024, United States
Excell Research
Oceanside, California, 92056, United States
Southern Ca Clinical Research, Inc.
Pasadena, California, 91106, United States
Stanford University
Stanford, California, 94305, United States
Los Angeles Biomedical Research Institute
Torrance, California, 90502, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Health Sciences America, Llc
Boca Raton, Florida, 33432, United States
Cns Clinical Research Group
Coral Springs, Florida, 33065, United States
Act Clinical Research Institute, Llc
Daytona Beach, Florida, 32124, United States
Neuropsychiatric Research Center Of Southwest Florida
Fort Myers, Florida, 33912, United States
Aurora-Cuervo Clinical Trials
Miami, Florida, 33143, United States
Gulf Coast Medical Research
Port Charlotte, Florida, 33952, United States
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407, United States
Comprehensive Neuroscience, Inc
Atlanta, Georgia, 30328, United States
Valle Vista Health System
Greenwood, Indiana, 46143, United States
Clinco
Terre Haute, Indiana, 47802, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206, United States
Clinical Research Institute
Wichita, Kansas, 67213, United States
University Of Kentucky, Dept. Of Psychiatry
Lexington, Kentucky, 40509, United States
Owensboro Behavioral Care
Owensboro, Kentucky, 42301, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21285, United States
Clinical Insights
Glen Burnie, Maryland, 21061, United States
Capital Clinical Research Associates
Rockville, Maryland, 20852, United States
Psychopharmacology Research Corporation
Farmington Hills, Michigan, 48334, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
University Of Medicine & Dentistry Of New Jersey
Cherry Hill, New Jersey, 08002, United States
Buffalo Psychiatric Center
Buffalo, New York, 14213, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Zarzar Psychiatric Associates, Pllc
Raleigh, North Carolina, 27607, United States
Horizon Medical Services
Bismarck, North Dakota, 58501, United States
Neuro Behavioral Clinical Research, Inc.
Canton, Ohio, 44708, United States
Community Research
Cincinnati, Ohio, 45227, United States
Saroj Brar Md, Inc
Cleveland, Ohio, 44113, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cutting Edge Research
Oklahoma City, Oklahoma, 73116, United States
Summit Research Network
Portland, Oregon, 97210, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104, United States
Dubois Regional Medical Center
DuBois, Pennsylvania, 15801, United States
Freimer, Martin
East Stroudsburg, Pennsylvania, 18301, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, 19131, United States
Cns Research Institute
Philadelphia, Pennsylvania, 19149, United States
Ut Medical Group/Odyssey Research
Memphis, Tennessee, 38105, United States
Psychiatric Consultants, Pc
Nashville, Tennessee, 37203, United States
Harmony Research, Llc
Piney Flats, Tennessee, 37686, United States
Bayou City Research, Ltd.
Houston, Texas, 77007, United States
Alamo Superior Research
San Antonio, Texas, 78229, United States
University Of Virginia Health System
Charlottesville, Virginia, 22903, United States
Windwood Centre
Virginia Beach, Virginia, 23452, United States
Pacific Institute Of Medical Sciences
Bothell, Washington, 98011, United States
Summit Research Network (Seattle) Llc
Seattle, Washington, 98104, United States
Health Research Center
Morgantown, West Virginia, 26506, United States
Aurora Health Care
Milwaukee, Wisconsin, 53233, United States
Local Institution
Cabo Rojo, 00623, Puerto Rico
Local Institution
Ponce, 00731, Puerto Rico
Local Institution
Rio Piedras, 00926, Puerto Rico
Local Institution
San Juan, 00918, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Otsuka
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2006
First Posted
January 16, 2006
Study Start
December 1, 2005
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
May 13, 2026
Results First Posted
October 20, 2010
Record last verified: 2026-04