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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
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).
Details
| Lead sponsor | Stony Brook University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2004-01 |
| Completion | 2007-07 |
Conditions
- Attention Deficit Disorder With Hyperactivity
- Conduct Disorder
- Oppositional Defiant Disorder
Interventions
- Divalproex Sodium
- Methylphenidate
- Dextroamphetamine
- Mixed Amphetamine Salts
- Family Counseling
- Behavior Management Training with Parents
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)
Countries
United States