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

Tracking Information
First Submitted Date ICMJE	September 26, 2005
First Posted Date ICMJE	September 28, 2005
Last Update Posted Date	October 31, 2013
Study Start Date ICMJE	January 2004
Actual Primary Completion Date	July 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 12, 2006)	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)
Original Primary Outcome Measures ICMJE; (submitted: September 26, 2005)	Score on an overt aggression scale; measured after 8 weeks of treatment; Score on the Clinical Global Improvement scale; measured after 8 weeks of treatment; Score on an ADHD rating scale; measured throughout the study
Change History	Complete list of historical versions of study NCT00228046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
Official Title ICMJE	Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder
Brief Summary	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	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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Attention Deficit Disorder With Hyperactivity; Conduct Disorder; Oppositional Defiant Disorder
Intervention ICMJE	Drug: Divalproex Sodium; Drug: Methylphenidate; Drug: Dextroamphetamine; Drug: Mixed Amphetamine Salts; Behavioral: Family Counseling; Behavioral: Behavior Management Training with Parents
Study Arms	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: September 26, 2005)	40
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2007
Actual Primary Completion Date	July 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	6 Years to 14 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00228046
Other Study ID Numbers ICMJE	K23MH064975( U.S. NIH Grant/Contract ); K23MH064975 ( U.S. NIH Grant/Contract ); M01RR010710 ( U.S. NIH Grant/Contract ); DSIR CT-M1
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Joseph Blader, Stony Brook University Medical Center
Study Sponsor ICMJE	Stony Brook University
Collaborators ICMJE	National Institute of Mental Health (NIMH)
Investigators ICMJE	Principal Investigator: Joseph C. Blader, PhD, MSc Stony Brook State University of New York School of Medicine
PRS Account	Stony Brook University
Verification Date	October 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP