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

Primary Purpose

Mood Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Divalproex Sodium (Depakote)
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders focused on measuring Behavioral Disorders

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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fighting per month Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant History of an EMD for one year without treatment EMD symptoms resulting in impairment in two or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

Sites / Locations

  • New York State Psychiatric Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00217932
Brief Title
Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings
Official Title
Double-Blind, Placebo-Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders
Keywords
Behavioral Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium (Depakote)
Primary Outcome Measure Information:
Title
Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Donovan, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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