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
  Purpose

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.


Condition Intervention Phase
Mood Disorders
Drug: Divalproex Sodium (Depakote)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12

Estimated Enrollment: 15
Study Start Date: September 2000
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217932

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen Donovan, MD Columbia University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00217932     History of Changes
Other Study ID Numbers: NIDA-00451-1, K02-00451-1, DPMC
Study First Received: September 16, 2005
Last Updated: April 27, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 22, 2014