Maintenance Treatment of Bipolar Depression

Phase 4

Completed

• Conditions: Depression; Bipolar Disorder
• Interventions: Drug: Lamotrigine; Drug: Placebo; Drug: Divalproex (DIV) ER

• Registration Number: NCT00183469
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2009-02
• Study Completion: 2009-04
• Results First Submitted: 2013-04-10
• Results First Submitted QC: 2015-04-15
• Results First Posted: 2015-04-20
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lamotrigine plus placebo divalproex ER	Placebo	Participants will take active lamotrigine and placebo
lamotrigine plus divalproex ER	Divalproex (DIV) ER	Participants will take active lamotrigine and active divalproex ER
lamotrigine plus divalproex ER	Lamotrigine	Participants will take active lamotrigine and active divalproex ER
lamotrigine plus placebo divalproex ER	Lamotrigine	Participants will take active lamotrigine and placebo

Primary Outcome Measures

Name	Time	Method
Mania Rating Scale	up to 8 months	Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.