Mood Disorders Clinical Trial
Official title:
Double-Blind, Placebo-Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings
Verified date | April 2006 |
Source | National Institute on Drug Abuse (NIDA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | August 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 11 Years |
Eligibility |
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fighting per month - Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant - History of an EMD for one year without treatment - EMD symptoms resulting in impairment in two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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12 |
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