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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • 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)

Estimated Enrollment: 40
Study Start Date: January 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228046

Locations
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
Investigators
Principal Investigator: Joseph C. Blader, PhD, MSc Stony Brook State University of New York School of Medicine
  More Information

No publications provided by Stony Brook University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Blader, Stony Brook University Medical Center
ClinicalTrials.gov Identifier: NCT00228046     History of Changes
Other Study ID Numbers: K23 MH64975, K23MH064975, M01 RR10710, DSIR CT-M1
Study First Received: September 26, 2005
Last Updated: October 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Stony Brook University:
ADHD
ODD
Conduct Disorder
CD

Additional relevant MeSH terms:
Disease
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Dextroamphetamine
Valproic Acid
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on September 18, 2014