MedTrace Logo

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

NCT02456454 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-12-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Risperidone

Liquid risperidone

DRUG

Valproic Acid

Liquid valproic acid

DRUG

Placebo

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Robert A Kowatch, MD, PhD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-06-30
Completion
2010-06-30

More Related Trials

Entities

Drugs
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 NCT02456454 on ClinicalTrials.gov