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

Sponsor

Stony Brook University (Other)

Overall Status

Completed

CT.gov ID

NCT00228046

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2004

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Long Island Jewish Medical Center / Schneider Children's Hospital	New Hyde Park	New York	United States	11042
2	Stony Brook University Hospital	Stony Brook	New York	United States	11794-8790