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

New York State Psychiatric Institute

Status and phase: Completed; Phase 3

Conditions: Attention Deficit and Disruptive Behavior Disorders; Marijuana Abuse

Treatments: Drug: Placebo; Drug: Divalproex Sodium

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00218114

#4767R

R01DA012234 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Drug: Divalproex Sodium

2

Placebo Comparator group

Description:

This is a parallel groups design lasting a total of six weeks. Participants will be on matching placebo for 250 mgs divalproex sodium (Depakote).

Treatment:

Drug: Placebo