An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

Summary

The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

Timeline

Start

2003-03

Primary completion

—

Completion

—

Outcome

Missed primary endpoint

paper A treatment effect was not observed with divalproex ER based on change in mean YMRS score PMID 19325497 ↗

paper The results of the study do not provide support for the use of divalproex ER in the treatment of youths with bipolar I disorder PMID 19325497 ↗

Publications

• Wagner KD, Redden L, Kowatch RA, Wilens TE, Segal S, Chang K, Wozniak P, Vigna NV, Abi-Saab W, Saltarelli M. A double-blind, randomized, placebo-controlled trial of divalproex extended-release in the treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):519-532. doi: 10.1097/CHI.0b013e31819c55ec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Divalproex Sodium	Small molecule	—	—

Indications