Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
NCT ID: NCT00228046
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2004-01-31
2007-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Divalproex Sodium
Methylphenidate
Dextroamphetamine
Mixed Amphetamine Salts
Family Counseling
Behavior Management Training with Parents
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of opposition defiant disorder or conduct disorder
* Score that exceeds the study threshhold on the standardized scale of aggressive behavior
Exclusion Criteria
* Current major depression
* Current pervasive developmental disorder
* Current obsessive compulsive disorder
* Any other anxiety disorder as primary diagnosis
* Mental retardation
6 Years
14 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Stony Brook University
OTHER
Responsible Party
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Stony Brook University Medical Center
Principal Investigators
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Joseph C. Blader, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
Stony Brook State University of New York School of Medicine
Locations
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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
Countries
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References
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Blader JC, Pliszka SR, Kafantaris V, Sauder C, Posner J, Foley CA, Carlson GA, Crowell JA, Margulies DM. Prevalence and Treatment Outcomes of Persistent Negative Mood Among Children with Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior. J Child Adolesc Psychopharmacol. 2016 Mar;26(2):164-73. doi: 10.1089/cap.2015.0112. Epub 2016 Jan 8.
Blader JC, Pliszka SR, Kafantaris V, Foley CA, Crowell JA, Carlson GA, Sauder CL, Margulies DM, Sinha C, Sverd J, Matthews TL, Bailey BY, Daviss WB. Callous-unemotional traits, proactive aggression, and treatment outcomes of aggressive children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2013 Dec;52(12):1281-93. doi: 10.1016/j.jaac.2013.08.024. Epub 2013 Sep 25.
Blader JC, Schooler NR, Jensen PS, Pliszka SR, Kafantaris V. Adjunctive divalproex versus placebo for children with ADHD and aggression refractory to stimulant monotherapy. Am J Psychiatry. 2009 Dec;166(12):1392-401. doi: 10.1176/appi.ajp.2009.09020233. Epub 2009 Nov 2.
Other Identifiers
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