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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

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Lamotrigine + Aripiprazole (Drug); Lamotrigine + Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)

Secondary outcome:

Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2

Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)

Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)

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

Adjusted Mean Change From Baseline in Body Weight, Phase 2

Number of Participants Showing Clinically Relevant Weight Loss by Study Week

Number of Participants Showing Clinically Relevant Weight Gain by Study Week

Adjusted Mean Change From Baseline in BMI by Study Week

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment

Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment

Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)

Summary of Concomitant Medications, Phase 1

Summary of Concomitant Medications, Phase 2

Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score

Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

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, St. 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

Cutting Edge Research, Oklahoma City, Oklahoma 73116, United States

University Of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Summit Research Network, Portland, Oregon 97210, United States

Lehigh Center For Clinical Research, Allentown, Pennsylvania 18104, United States

Lehigh Valley Hospital, Allentown, Pennsylvania 18103, United States

Dubois Regional Medical Center, Dubois, Pennsylvania 15801, United States

Freimer, Martin, East Stroudsburg, Pennsylvania 18301, United States

Belmont Center For Comprehensive Treatment, Philadelphia, Pennsylvania 19131, United States

Cns Research Institute, Philadelphia, Pennsylvania 19149, United States

University Of Pennsylvania, Philadelphia, Pennsylvania 19104, 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

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2005
Last updated: November 7, 2013

Page last updated: August 23, 2015

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