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

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00217932

First received: September 16, 2005

Last updated: April 27, 2006

Last verified: April 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

April 27, 2006

Start Date ^ICMJE

September 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00217932 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Mood Disorders

Intervention ^ICMJE

Drug: Divalproex Sodium (Depakote)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00217932

Other Study ID Numbers ^ICMJE

NIDA-00451-1, K02-00451-1, DPMC

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stephen Donovan, MD

Columbia University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

April 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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