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

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Placebo; Drug: Risperidone; Drug: Valproic Acid

• Registration Number: NCT02456454
• Lead Sponsor: Nationwide Children's Hospital

Brief 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.

Detailed Description

The objective of this study was to study 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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-28
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Liquid placebo PO matched for color and taste.
Risperidone	Risperidone	Risperidone, PO 0.25-2 mg/day
Valproic	Valproic Acid	Valproic Acid PO to achieve plasma levels of 85-100

Primary Outcome Measures

Name	Time	Method
Young Mania Rating Scale	6 weeks	Young Mania Rating Scale

Secondary Outcome Measures

Name	Time	Method
Clinical Global Improvement Scale	6 weeks	Clinical Global Improvement Scale