Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
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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 |
- 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) |
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 |
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| 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 | |
| Principal Investigator: | Joseph C. Blader, PhD, MSc | Stony Brook State University of New York School of Medicine |
More Information
No publications provided by National Institute of Mental Health (NIMH)
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, M01 RR10710, DSIR CT-M1 |
| Study First Received: | September 26, 2005 |
| Last Updated: | February 29, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
ADHD ODD Conduct Disorder CD |
Additional relevant MeSH terms:
|
Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder with Hyperactivity Conduct Disorder Hyperkinesis Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Amphetamine Dextroamphetamine Methylphenidate Valproic Acid Central Nervous System Stimulants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Anticonvulsants |
ClinicalTrials.gov processed this record on June 18, 2013