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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00218114
First received: September 16, 2005
Last updated: March 6, 2014
Last verified: December 2012

September 16, 2005
March 6, 2014
February 2000
January 2015   (final data collection date for primary outcome measure)
Symptoms of disruptive behavior disorder (measured throughout the study and at Week 6) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00218114 on ClinicalTrials.gov Archive Site
Not Provided
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Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults
Parallel Groups Study of Divalproex Sodium (Depakote) for Irritable, Explosive Adults & Adolescents

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Attention Deficit and Disruptive Behavior Disorders
  • Marijuana Abuse
  • 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
  • Experimental: 1
    Divalproex sodium (Depakote)
    Interventions:
    • Drug: Divalproex Sodium (Depakote)
    • Drug: divalproex sodium
  • Placebo Comparator: 2
    matching placebo for 250 mgs divalproex sodium
    Intervention: Drug: divalproex sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
12 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218114
#4767R, R01DA012234, DPMC
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Stephen Donovan, MD New York State Psychiatric Institute
New York State Psychiatric Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP