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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218114
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 10, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Attention Deficit and Disruptive Behavior Disorders Marijuana Abuse Drug: Divalproex Sodium Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Actual Study Start Date : February 2000
Actual Primary Completion Date : February 18, 2005
Actual Study Completion Date : February 18, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
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).
Drug: Placebo
Participants will be on matching placebo.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00218114

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Stephen Donovan, MD New York State Psychiatric Institute

Responsible Party: New York State Psychiatric Institute Identifier: NCT00218114     History of Changes
Other Study ID Numbers: #4767R
R01DA012234 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by New York State Psychiatric Institute:
ADHD, disruptive behavior disorder, marijuana abuse

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Marijuana Abuse
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Behavioral Symptoms
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs