This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This study hypothesizes that aripiprazole, which has been shown to be effective in the treatment of psychotic and manic-depressive disorders, will be more effective than placebo in reducing the severity of explosive outbursts in children and adolescents with Tourette's Disorder (TD), as assessed by measuring the frequency, intensity, and duration of explosive outbursts. The study will test the efficacy and safety of a relatively safe drug when used in adults as a treatment of TD in children and adolescents. The endpoints are a variety of different neuropsychiatric tests, administered by the staff, that will measure tic, frequency, anger, range, and outbursts. A newly devised test, the Rage Severity Scale, will be administered, and the effects of treatment measured on this scale will be compared to more traditional assessments. The study is a placebo-controlled, 6-week trial with increasing doses of aripiprazole versus placebo. Treatment and placebo groups of 15 are planned, as early information suggests a very significant impact of this drug in TD (p<10-12) using a small number of treated individuals. Within-person changes will be assessed longitudinally.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000096-46
Application #
7605767
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-04-01
Project End
2008-03-31
Budget Start
2007-04-01
Budget End
2008-03-31
Support Year
46
Fiscal Year
2007
Total Cost
$3,945
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
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