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

December 10, 2018 updated by: Robert Kowatch, Nationwide Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Subjects were male or female outpatient subjects,
  • 3.0 - 7 years 11 months of age
  • Bipolar I or II Disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to DSM IV criteria (American Psychiatric Association 1994)
  • with a score > 20 on the Young Mania Rating Scale (YMRS.

Exclusion Criteria

  • clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions;

  • neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests:

    • CBC with differential,
    • electrolytes,
    • BUN,
    • creatinine,
    • hepatic transaminases,
    • urinalysis,
    • thyroid indices (T3, Total T4, Free T4, TSH) and
    • EKG
  • mania due to a general medical condition or substance-induced mania
  • mental retardation (IQ <70),
  • evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder,
  • Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risperidone
Risperidone, PO 0.25-2 mg/day
Drug: Risperidone
Liquid risperidone
Other Names:
  • Risperdal
Experimental: Valproic
Valproic Acid PO to achieve plasma levels of 85-100
Drug: Valproic Acid
Liquid valproic acid
Other Names:
  • Valproate
Placebo Comparator: Placebo
Liquid placebo PO matched for color and taste.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Young Mania Rating Scale
Time Frame: 6 weeks
Young Mania Rating Scale
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Improvement Scale
Time Frame: 6 weeks
Clinical Global Improvement Scale
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Collaborators

Stanley Medical Research Institute

Investigators

  • Principal Investigator: Robert A Kowatch, MD, PhD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHMC#03-12-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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