Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

Phase 3 Completed 46 enrolled Nationwide Children's Hospital Stanley Medical Research Institute · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.

Timeline

Start: 2006-01
Primary completion: 2010-06
Completion: 2010-06

Publications

Results Kowatch RA, Scheffer RE, Monroe E, Delgado S, Altaye M, Lagory D. Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):306-13. doi: 10.1089/cap.2014.0166.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risperidone	Other / unclassified	0.25 mg	Oral
Subject	Risperidone	Other / unclassified	2 mg	Oral
Subject	Valproic Acid	Small molecule	—	Oral

Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

Summary

Timeline

Publications

Drugs

Indications