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

This study is ongoing, but not recruiting participants.

First Received: January 13, 2006 Last Updated: June 17, 2009 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00277212

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder	Drug: Lamotrigine + Aripiprazole Drug: Lamotrigine + Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine Aripiprazole

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The primary efficacy measure will be the time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase (Phase 2) [ Time Frame: up to 52 weeks maximum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to any relapse (manic, mixed, depressive) in the Double-blind Relapse Assessment Phase [ Time Frame: up to 52 weeks maximum ] [ Designated as safety issue: No ]
Time to Depressive relapse, in the Double-blind Relapse Assessment Phase [ Time Frame: up to 52 weeks maximum ] [ Designated as safety issue: No ]
Time to discontinuation for any reason in the Double-blind Relapse Assessment Phase [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	December 2005
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	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
A2: Placebo Comparator	Drug: Lamotrigine + Placebo Tablets, Oral, once daily, Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day placebo 0 mg/day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277212

Locations

United States, California
Pacific Clinical Research Medical Group
Upland, California, United States, 91786
United States, Florida
Health Sciences America, Llc
Boca Raton, Florida, United States, 33432
Janus Center For Psychiatric Research
West Palm Beach, Florida, United States, 33407
United States, Indiana
Valle Vista Health System
Greenwood, Indiana, United States, 46143
United States, Kansas
Clinical Trials Technology, Inc
Prarie Village, Kansas, United States, 66206
United States, Kentucky
University Of Kentucky, Dept. Of Psychiatry
Lexington, Kentucky, United States, 40509
United States, Maryland
Clinical Insights
Glen Burnie, Maryland, United States, 21061
United States, New York
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, North Carolina
Zarzar Psychiatric Associates, Pllc
Raleigh, North Carolina, United States, 27607
Duke Univeristy Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Saroj Brar Md, Inc
Cleveland, Ohio, United States, 44113
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Pacific Institute Of Medical Sciences
Bothell, Washington, United States, 98011
Puerto Rico
Local Institution
Ponce, Puerto Rico, 00731

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN138-392 ST
Study First Received:	January 13, 2006
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00277212 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Bipolar I Disorder with a recent manic or mixed episode

Study placed in the following topic categories:

Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Calcium Channel Blockers
Cardiovascular Agents
Antipsychotic Agents
Calcium, Dietary

Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Lamotrigine
Psychotic Disorders
Aripiprazole
Anticonvulsants

Additional relevant MeSH terms:

Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Calcium Channel Blockers
Cardiovascular Agents
Antipsychotic Agents
Pharmacologic Actions

Membrane Transport Modulators
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
Aripiprazole
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 02, 2009