drugset / Trial / NCT00221403

Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders

NCT00221403

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary aim of this proposal is to conduct a preliminary controlled trial of valproate and risperidone in children ages 3-7 yr. with bipolar disorders. A secondary aim is to carefully characterize these subjects using clinical rating scales and develop pilot data on a very young cohort of children with bipolar disorders that can be used to support an application to NIMH for a prospective, longitudinal study that will provide important information about the course, medication response, neurobiology and outcome of these patients.

Timeline

Start
2004-09
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Risperidone Other / unclassified Oral
Comparator Valproate Small molecule 10 mg/kg Oral

Indications