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 - Tabular View

Tracking Information

First Received Date ^ICMJE

January 13, 2006

Last Updated Date

November 16, 2009

Start Date ^ICMJE

December 2005

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy measure will be the time from randomization to relapse to a manic or mixed episode

Change History

Complete list of historical versions of study NCT00277212 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

- Time to any relapse
- Time to depressive relapse
- 52 week completers

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: Lamotrigine + Aripiprazole
Drug: Lamotrigine + Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

349

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00277212

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CN138-392 ST

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Otsuka America Pharmaceutical

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP