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Parallel Groups Study of Divalproex Sodium (Depakote) for Irritable, Explosive Adults & Adolescents

This study is currently Recruiting

August 2008 By National Institute on Drug Abuse (NIDA)

First Recieved on September 16, 2005

Last Updated on August 19, 2008

Sponsor: National Institute on Drug Abuse (NIDA)
Collaborators:
Information provided by: National Institute on Drug Abuse (NIDA)
Identifier: NCT00218114

Purpose

The purpose of this study is to compare the effectiveness of divalproex sodium (Depakote) versus placebo in treating disruptive behavior disorder and explosive tempers in adolescents and adults.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:12 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Meets DSM-IV criteria for a disruptive behavior disorder (e.g., oppositional/defiant disorder, conduct disorder) - Explosive temper, defined as four or more outbursts of rage, property destruction, or fighting per month - Mood liability, defined as having multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior - Chronic symptoms, defined of at least 1 year duration when not receiving treatment - Impairment from the above symptoms in two or more areas, including school, the law, family, substance use, peers, or work (as manifested by a GAF score of 55 or less) - Symptoms not limited to a particular place or to particular intimate relationships - General good health - Custodial parent or guardian gives informed consent Exclusion Criteria: - History of non drug-induced psychosis - Seizure or other neurologic disturbance - Pregnant - Moderate to severe mental retardation - Sexually active females who refuse to use an adequate method of contraception for the duration of the study - Significant medical problems - Current suicidal or homicidal ideation - Uses barbiturates - Refusal to permit weekly contact with school officials - Bipolar I or II disorder - Major depressive disorder - First degree relative with bipolar I or II disorder - Attention deficit/hyperactivity disorder - Post traumatic stress disorder - Clinical evidence of hyperandrogenism in a female - Liver disease - Thrombocytopenia - Pancreatic disease

Investigators

  • Investigator: Stephen Donovan, MD - Principal Investigator - New York State Psychiatric Institute

Locations

  • New York State Psychiatric Institute

    New York, New York 10032 United States

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