A Phase 4 interventional study of Divalproex Sodium and Methylphenidate in Attention Deficit Disorder With Hyperactivity, Conduct Disorder and Oppositional Defiant Disorder, sponsored by Stony Brook University. Completed at 2 sites in United States. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2013-10-31.
Sponsored by Stony Brook University · Phase 4, Interventional, and Treatment
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Stony Brook University