drugset / Trial / NCT00221403
Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
Phase 3
Completed
46 enrolled
Children's Hospital Medical Center, Cincinnati
Stanley Medical Research Institute · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Risperidone | Other / unclassified | — | Oral |
| Comparator | Valproate | Small molecule | 10 mg/kg | Oral |