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

Stony Brook University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Attention Deficit Disorder With Hyperactivity Conduct Disorder Oppositional Defiant Disorder

Interventions

Divalproex SodiumDRUG

MethylphenidateDRUG

DextroamphetamineDRUG

Mixed Amphetamine SaltsDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (2)

Long Island Jewish Medical Center / Schneider Children's Hospital

New Hyde Park, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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