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

NCT ID: NCT00218114

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2005-02-18

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Divalproex Sodium

Intervention Type: DRUG

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.

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will be on matching placebo.

Interventions

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.

Intervention Type: DRUG

Placebo

Participants will be on matching placebo.

Intervention Type: DRUG

Other Intervention Names

Depakote

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Donovan, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

R01DA012234

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#4767R

Identifier Type: -

Identifier Source: org_study_id