Maintenance Treatment of Bipolar Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 30, 2009

Start Date ^ICMJE

December 2004

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Rates of response to treatment regimen [ Time Frame: Measured at Week 32 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Rates of response to treatment regimen

Change History

Complete list of historical versions of study NCT00183469 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Maintenance Treatment of Bipolar Depression

Official Title ^ICMJE

Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination

Brief Summary

This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.

Detailed Description

Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.

Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder
Depression

Intervention ^ICMJE

Drug: Lamotrigine (LAM)
Drug: Divalproex (DIV)
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Participants will take active lamotrigine and active divalproex
Placebo Comparator: Participants will take active lamotrigine and placebo

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

Estimated Enrollment ^ICMJE

170

Completion Date

April 2009

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of bipolar disorder I or II
Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
Willing to use acceptable methods of contraception
Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

History of liver disease
History of substance abuse
Previous treatment with lamotrigine or divalproex
Lamotrigine or divalproex intolerance

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

NCT00183469

Responsible Party

Charles L. Bowden, University of Texas Health Science Center at SanAntonio

Study ID Numbers ^ICMJE

P20 MH68662, DSIR 83-ATSO

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Charles L. Bowden, MD

210-567-5405

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

June 2009

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