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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder

Conditions
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Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Oppositional Defiant Disorder

Intervention / Treatment
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* Drug: Divalproex Sodium
* Drug: Methylphenidate
* Drug: Dextroamphetamine
* Drug: Mixed Amphetamine Salts
* Behavioral: Family Counseling
* Behavioral: Behavior Management Training with Parents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Divalproex Sodium|nan|
|Drug: Methylphenidate|nan|
|Drug: Dextroamphetamine|nan|
|Drug: Mixed Amphetamine Salts|nan|
|Behavioral: Family Counseling|nan|
|Behavioral: Behavior Management Training with Parents|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, ODD, Conduct Disorder, CD