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

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

Sponsors

Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborator: Otsuka America Pharmaceutical

Source Otsuka Pharmaceutical Development & Commercialization, Inc.
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

Overall Status Completed
Start Date December 2005
Completion Date July 2009
Primary Completion Date July 2009
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of Participants Not Experiencing Relapse Through Week 52 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
Secondary Outcome
Measure Time Frame
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
Number of Participants Showing Clinically Relevant Weight Loss by Study Week Weeks 12, 24, 36, 52
Number of Participants Showing Clinically Relevant Weight Gain by Study Week Weeks 12, 24, 36, 52
Adjusted Mean Change From Baseline in BMI by Study Week Baseline, Weeks 12, 24, 36, 52
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment Throughout the study, up to Week 52
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment Up to 52 Weeks
Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2) Throughout Phase 2 of the study, up to Week 52
Summary of Concomitant Medications, Phase 1 Phase 1 (9 to 24 Week Single-blind Stabilization Phase)
Summary of Concomitant Medications, Phase 2 Phase 2 (52 Week Double-blind Relapse Assessment Phase)
Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score Baseline, Weeks 8, 24, 36, 52
Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score Baseline, Weeks 8, 24, 36, 52
Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment, Baseline, Weeks 8, 24, 36, 52
Enrollment 1169
Condition
Intervention

Intervention type: Drug

Intervention name: Lamotrigine + Aripiprazole

Description: 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

Arm group label: A1

Intervention type: Drug

Intervention name: Lamotrigine + Placebo

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

Arm group label: A2

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Location
facility
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
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
Location Countries

Puerto Rico

United States

Verification Date

November 2010

Responsible Party

Name title: Study Director

Organization: Bristol-Myers Squibb

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A1

Arm group type: Experimental

Description: Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole

Arm group label: A2

Arm group type: Placebo Comparator

Description: Phase 2 Double-Blind Treatment: Lamotrigine + Placebo

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov