MedTrace Logo

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

NCT00221403 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-10-20

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Risperidone oral solution

liquid, BID dosing.

DRUG

Valproate Oral Solution

liquid, BID dosing.

OTHER

Placebo

liquid, BID dosing.

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Robert A Kowatch, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2011-05-31
Completion
2011-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00221403 on ClinicalTrials.gov