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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by New York State Psychiatric Institute.
Recruitment status was:  Active, not recruiting
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute Identifier:
First received: September 16, 2005
Last updated: March 6, 2014
Last verified: December 2012
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 Intervention Phase
Attention Deficit and Disruptive Behavior Disorders
Marijuana Abuse
Drug: Divalproex Sodium (Depakote)
Drug: divalproex sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Parallel Groups Study of Divalproex Sodium (Depakote) for Irritable, Explosive Adults & Adolescents

Resource links provided by NLM:

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Symptoms of disruptive behavior disorder (measured throughout the study and at Week 6) [ Time Frame: 6 weeks ]

Estimated Enrollment: 75
Study Start Date: February 2000
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Divalproex sodium (Depakote)
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
Placebo Comparator: 2
matching placebo for 250 mgs divalproex sodium
Drug: divalproex sodium
divalproex sodium in 250 mgs doses titrated to 10 mgs /lb to reach a blood level between 50-110 micrograms/ml

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.


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: New York State Psychiatric Institute Identifier: NCT00218114     History of Changes
Other Study ID Numbers: #4767R
R01DA012234 ( US NIH Grant/Contract Award Number )
Study First Received: September 16, 2005
Last Updated: March 6, 2014

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Marijuana Abuse
Mental Disorders
Problem Behavior
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 processed this record on May 25, 2017