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

Marijuana Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218114
• Other study ID #: #4767R
• Secondary ID: R01DA012234
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: August 8, 2017
• Start date: February 2000
• Est. completion date: February 18, 2005

Study information

• Verified date: August 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 18, 2005
• Est. primary completion date: February 18, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Marijuana Abuse
• Mental Disorders
• Problem Behavior

Intervention

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.
• Placebo
Participants will be on matching placebo.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of disruptive behavior disorder	Measure symptoms of disruptive behavior disorder with the modified overt aggression scale throughout the study and at Week 6	6 weeks