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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00228046
First received: September 26, 2005
Last updated: October 29, 2013
Last verified: October 2013

September 26, 2005
October 29, 2013
January 2004
July 2007   (final data collection date for primary outcome measure)
  • Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment)
  • Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)
  • Score on an overt aggression scale; measured after 8 weeks of treatment
  • Score on the Clinical Global Improvement scale; measured after 8 weeks of treatment
  • Score on an ADHD rating scale; measured throughout the study
Complete list of historical versions of study NCT00228046 on ClinicalTrials.gov Archive Site
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Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Attention Deficit Disorder With Hyperactivity
  • Conduct Disorder
  • Oppositional Defiant Disorder
  • Drug: Divalproex Sodium
  • Drug: Methylphenidate
  • Drug: Dextroamphetamine
  • Drug: Mixed Amphetamine Salts
  • Behavioral: Family Counseling
  • Behavioral: Behavior Management Training with Parents
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00228046
K23 MH64975, K23MH064975, M01 RR10710, DSIR CT-M1
Not Provided
Joseph Blader, Stony Brook University Medical Center
Stony Brook University
National Institute of Mental Health (NIMH)
Principal Investigator: Joseph C. Blader, PhD, MSc Stony Brook State University of New York School of Medicine
Stony Brook University
October 2013

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