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

NCT00217932 | Completed Phase 2

• 3 other identifiers: NIDA-00451-1K02-00451-1DPMC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders

Keywords

Behavioral Disorders

Outcome Measures

Primary Outcomes (1)

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

Interventions

Divalproex Sodium (Depakote) DRUG

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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• Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Mood Disorders; Mental Disorders

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Stephen Donovan, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2000
• Study Completion: August 1, 2005
• Last Updated: January 12, 2017

Record last verified: 2006-04

Locations

US (1)