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

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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Divalproex Sodium (Depakote)
  • Subjects 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: divalproex sodium
  • divalproex sodium in 250 mgs doses titrated to 10 mgs /lb to reach a blood level between 50-110 micrograms/ml

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Divalproex sodium (Depakote)
• Placebo Comparator: 2
  • matching placebo for 250 mgs divalproex sodium

Primary Measures

• Symptoms of disruptive behavior disorder (measured throughout the study and at Week 6)
  • Time Frame: 6 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Stephen Donovan, MD Principal Investigator New York State Psychiatric Institute  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00218114

Study ID Number: NIDA-12234-1

ClinicalTrials.gov Identifier: NCT00218114

Health Authority: United States: Federal Government