Clinical Trial: Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

Disruptive behavior disorders among children and adolescents are readily diagnosed; however, few individuals with such disorders receive drug treatment. Depakote is a mood stabilizing medication that may be beneficial in treating individuals with disruptive behavior disorders. The purpose of this study is to examine the effectiveness of Depakote in reducing temper outbursts and improving mood in individuals with disruptive behavior disorders. In addition, this study will determine the safety and effectiveness of Depakote in treating individuals with substance disorders who also have disruptive behavior disorders.

This study will last 6 weeks. Participants will be randomly assigned to receive treatment with Depakote or placebo. Medication will be given in a single evening dose if tolerated; otherwise, medication will be given twice per day. Participants will be assigned to a fixed-flexible dosing schedule and dosages will increase based on weight. All participants will attend weekly psychotherapy and family counseling sessions throughout the study. Participants who are substance abusers will also receive substance abuse counseling. Weekly study visits will include a physical exam, blood collection, and drug tests. Teachers and guidance counselors will be contacted to assess the participant's behavior from week to week. Some participants will complete a follow-up study, in which they will take part in phone interviews.

Sponsor: New York State Psychiatric Institute

Current Primary Outcome: Symptoms of disruptive behavior disorder (measured throughout the study and at Week 6) [ Time Frame: 6 weeks ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: New York State Psychiatric Institute

Dates:
Date Received: September 16, 2005
Date Started: February 2000
Date Completion: January 2015
Last Updated: March 6, 2014
Last Verified: December 2012