NCT00451542

Divalproex vs. Lamotrigine for Bipolar Disorder

Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Tuscaloosa Research & Education Advancement Corporation · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.

Detailed description

The primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). The primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. The secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.

Conditions

• Bipolar Disorder

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-05-01
• Completion: 2008-02-01
• First posted: 2007-03-23
• Last updated: 2017-04-27