Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents

NCT00195767 ↗

Phase 3 Completed 150 enrolled Abbott

Non-randomizedSingle-groupOpen-labelTreatment

Summary

To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.

Timeline

Start: 2004-07
Primary completion: —
Completion: —

Outcome

Missed primary endpoint

paper In the double-blind study, 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, mixed or manic state. 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	—	—