Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
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ClinicalTrials.gov Identifier: NCT00228046 |
Recruitment Status
:
Completed
First Posted
: September 28, 2005
Last Update Posted
: October 31, 2013
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |
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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 |