NCT00218114

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Attention Deficit and Disruptive Behavior Disorders
• Marijuana Abuse

Interventions

Type	Name	Description
DRUG	Divalproex Sodium	Participants are titrated over 2 weeks, as tolerated to 10 mgs / pound, and blood levels are checked to determine that the blood level is between 50-110 micrograms / ml.
DRUG	Placebo	Participants will be on matching placebo.

Timeline

• Start date: 2000-02-01
• Primary completion: 2005-02-18
• Completion: 2005-02-18
• First posted: 2005-09-22
• Last updated: 2017-08-10

Locations

1 site across 1 country: United States