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

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: NCT00228046
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : October 31, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Stony Brook University

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).

Condition or disease Intervention/treatment Phase
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 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder
Study Start Date : January 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment)
  2. Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00228046

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United States, New York
Long Island Jewish Medical Center / Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8790
Sponsors and Collaborators
Stony Brook University
National Institute of Mental Health (NIMH)
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Principal Investigator: Joseph C. Blader, PhD, MSc Stony Brook State University of New York School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Joseph Blader, Stony Brook University Medical Center Identifier: NCT00228046     History of Changes
Other Study ID Numbers: K23MH064975 ( U.S. NIH Grant/Contract )
K23MH064975 ( U.S. NIH Grant/Contract )
M01RR010710 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013
Keywords provided by Stony Brook University:
Conduct Disorder
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Valproic Acid
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors