Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults
|Attention Deficit and Disruptive Behavior Disorders Marijuana Abuse||Drug: Divalproex Sodium Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Parallel Groups Study of Divalproex Sodium (Depakote) for Irritable, Explosive Adults & Adolescents|
- Symptoms of disruptive behavior disorder [ Time Frame: 6 weeks ]Measure symptoms of disruptive behavior disorder with the modified overt aggression scale throughout the study and at Week 6
|Actual Study Start Date:||February 2000|
|Study Completion Date:||February 18, 2005|
|Primary Completion Date:||February 18, 2005 (Final data collection date for primary outcome measure)|
Divalproex sodium (Depakote). This is a parallel groups design lasting a total of six weeks. Participants will be on a fixed-flexible dosing schedule. The dose of depakote will be raised to 750mgs or 1000mgs, depending on weight, in two weeks to achieve blood levels between 50-130 micrograms per milliliter. If a patient does not achieve this blood level on 750mgs or 1000 mgs, the dose may be raised during the second week.
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.
Other Name: Depakote
Placebo Comparator: 2
This is a parallel groups design lasting a total of six weeks. Participants will be on matching placebo for 250 mgs divalproex sodium (Depakote).
Participants will be on matching placebo.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218114
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Stephen Donovan, MD||New York State Psychiatric Institute|