Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

Double-Blind, Placebo-Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings

The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote) versus placebo in treating children with temper outbursts and severe mood disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depakote has been used to treat seizures in children for more than 20 years. The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote) in treating children with temper outbursts and severe mood disorders.

This study will last 12 weeks. Participants will be randomly assigned to receive either 250 mg Depakote or placebo. The dose of medication will increase at the end of Week 1 to 500 mg of either depakote or placebo; participants will remain on this dose through Week 5. At Week 6, participants will cross-over and receive the other treatment (either depakote or placebo), which they will take through Week 12. Study visits will occur weekly and will include a physical exam, blood and urine tests, and self-reports of adverse events. In addition, caregivers will complete reports about mood swings throughout the study.

Study Type

Interventional

Enrollment

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

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:

  • Meets criteria for Explosive Mood Disorder (EMD)
  • Explosive temper as evidenced by four or more outbursts of rage, property destruction, or fighting per month
  • Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant
  • History of an EMD for one year without treatment
  • EMD symptoms resulting in impairment in two or more of the following areas: school, the law, family, substance use, peers, or work
  • EMD symptoms do not occur only during substance toxicity or withdrawal
  • EMD symptoms are not confined to a single setting or context
  • Parent and child willing to consent to study
  • Inadequate response to an adequate trial (8 weeks) of psychotherapy and/or family therapy

Exclusion Criteria:

  • Meets criteria for pervasive developmental disorder or childhood schizophrenia
  • Seizure or other neurologic disturbance
  • Pregnant
  • Moderate to severe mental retardation
  • Physical exam or laboratory results with significant abnormalities
  • Positive Hepatitis screen test
  • Liver dysfunction
  • Active suicidal or homicidal ideation
  • History of suicide attempts
  • History of barbiturate use
  • Unequivocal manic or hypomanic episode
  • Meets criteria for attention deficit hyperactivity disorder (ADHD) and has not failed a trial of psychostimulants for ADHD
  • Meets criteria for major depression in prepuberty
  • If female, unwilling to use an effective method of contraception for the duration of the study
  • Mitochondrial disease or family history of mitochondrial disease

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: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12

Collaborators and Investigators

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

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Stephen Donovan, MD, Columbia University

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

September 1, 2000

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-00451-1
  • DPMC (Other Identifier: NIDA)
  • K02-00451-1

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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