This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PURPOSE OF THE STUDY The purpose of the TEAM study is to evaluate the usefulness of three different medicines for children and teenagers ages 6 to 15.11 with mania. Mania is a term used to describe an illness in which children may feel so good or irritable leading to behavior that impairs their functioning. The three study medications are lithium, valproate, and risperidone. DESCRIPTION OF THE STUDY There are 3 parts to the TEAM study. The first part of the TEAM study is a baseline assessment. The second part is the medication treatment evaluation (8-16 weeks long). The last part is a 6-month follow-up assessment. Therefore, this study will take up to 10 months to complete. The study medications are risperidone (trade name Risperdal), lithium (trade name Eskalith), and valproate (trade name Depakote). These study medications are approved for use in adults with mania, but they have not yet been tested or approved by the FDA for treatment of mania in children or adolescents. There will be approximately 110 subjects participating here at Johns Hopkins. There will be up to 540 subjects participating in this study across the U.S.A.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000052-45
Application #
7378830
Study Section
Special Emphasis Panel (ZRR1-CR-1 (01))
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
45
Fiscal Year
2006
Total Cost
$12,467
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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