Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder

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Brief Title

Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder

Official Title

Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder

Brief Summary

      This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant
      treatment is more effective than stimulant treatment alone in reducing aggressive behavior
      among children with attention deficit hyperactivity disorder (ADHD).
    

Detailed Description

      ADHD is one of the most common childhood mental disorders. It often causes impaired
      functioning in multiple areas, including home, school, and peer relationships. Additionally,
      children with ADHD often develop aggressive behavior, which is not usually adequately
      suppressed by standard stimulant treatments for ADHD. In order to address this problem, many
      physicians prescribe multiple medications at once. There is no clinical evidence, however,
      proving that this method is safe and effective. This study will assess whether adding a mood
      stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant
      treatment alone in reducing aggressive behavior among children with ADHD.

      Participants in this double blind study will first receive open label stimulant treatment for
      ADHD and a comorbid disruptive behavior disorder. Participants whose aggressive behavior
      subsides with stimulant treatment alone will not proceed into the next phase of the study.
      Participants whose ADHD symptoms lessen from the treatment but whose aggressive behavior
      persists will be randomly assigned to receive either divalproex sodium or placebo in addition
      to their stimulant treatment for 8 weeks. Study visits will be held weekly for 11 to 16
      weeks. At these visits, aggression levels and medication side effects will be assessed.
      Families will also meet with the researchers to discuss the child's progress, and attend
      behavioral counseling with a therapist. Participants who did not continue into the second
      phase of the study will be asked to return to the study site for a follow-up visit 8 weeks
      following the end of the first phase.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment)


Condition

Attention Deficit Disorder With Hyperactivity

Intervention

Divalproex Sodium


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

January 2004

Completion Date

July 2007

Primary Completion Date

July 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of ADHD

          -  Diagnosis of opposition defiant disorder or conduct disorder

          -  Score that exceeds the study threshhold on the standardized scale of aggressive
             behavior

        Exclusion Criteria:

          -  Current psychosis

          -  Current major depression

          -  Current pervasive developmental disorder

          -  Current obsessive compulsive disorder

          -  Any other anxiety disorder as primary diagnosis

          -  Mental retardation
      

Gender

All

Ages

6 Years - 14 Years

Accepts Healthy Volunteers

No

Contacts

Joseph C. Blader, PhD, MSc, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00228046

Organization ID

K23MH064975

Secondary IDs

K23MH064975


Study Sponsor

Stony Brook University

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

Joseph C. Blader, PhD, MSc, Principal Investigator, Stony Brook State University of New York School of Medicine


Verification Date

October 2013