Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder — PBC  

Bipolar Disorder Clinical Trial

Official title: Pediatric Bipolar Collaborative Mood Stabilizer Trial

Status Completed

Clinical Trial Summary

This study compared the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.

Clinical Trial Description

Primary Aim:

To compare the efficacy of lithium (LI), divalproex (DVP), and placebo (PBO) in the acute phase treatment of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents. Our hypothesis is that differential efficacy will be observed with the following predicted order of response: divalproex (DVP) = lithium (LI) > placebo (PBO).

Secondary Aims:

1. To collect systematic safety data on the incidence of weight gain and the development of insulin resistance and hyperandrogenism in bipolar adolescent females treated with LI, DVP, or LI + DVP.

2. To collect data on possible predictors of acute treatment response to the two active treatments.

3. To provide descriptive information on the stability of acute phase response to monotherapy with either LI or DVP over 6 months of continuation phase treatment.

4. To develop safety and efficacy data about the use of stimulant medications in these subject while treated with a mood stabilizer. ;

Related Conditions & MeSH terms

• Bipolar Disorder

• NCT number: NCT00221429
• Study type: Interventional
• Source: Children's Hospital Medical Center, Cincinnati
• Status: Completed
• Phase: Phase 3
• Start date: March 2001
• Completion date: February 2015