This proposal was developed in collaboration with NIMH Program staff and approved for submission by Council at its 1/18/01 meeting. The two aims are:(1) To investigate the effectiveness of medications for children and adolescents who have BP-1 (manic or mixed phase) or mania. (2) To pilot a complex, multistrata, adaptive strategy design. Based on the novelty of the design and on the need for a large (and therefore costly) sample size, the applicants were asked to submit a protocol for only the first two years of the five year plan. If the first two years are successfully implemented, funding for the additional three years will be sought. ? ? For the sake of clarity, the proposal is written for the entire five years, even though the budget is limited to the first two years. Thus, the research plan provides for examining 540 subjects ages 6.0-14.11 who have DSM BP-1 (manic or mixed phase) or mania. ? ? The structure of this collaborative R01 is one coordinating site and six data collection sites. The coordinating site, for data management and analyses and for training is Washington University, St. Louis, PI: Barbara Geller, M.D. The six sites for data collection are: (1) George Washington University, Washington, D.C.., PI: Paramjit Joshi, M.D. (2) Johns Hopkins Medical Instituitions, Baltimore, PI: John walkup, M.D. (3) University of Pittsburgh, Western Psychiatric Institute and Clinic, PI: David Axelson, M.D. (4) University of Texas, Dallas, PI: Graham Emslie, M.D. (5) University of Texas, Galveston, PI: Karen Dineen Wagner, M.D. and (6) Washington University, St. Louis, PI; Joan Luby, M.D.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01MH064887-02
Application #
6664971
Study Section
Special Emphasis Panel (ZMH1-NRB-G (06))
Program Officer
James, Regina Smith
Project Start
2002-09-21
Project End
2005-06-23
Budget Start
2003-09-01
Budget End
2005-06-23
Support Year
2
Fiscal Year
2003
Total Cost
$461,560
Indirect Cost
Name
Children's Research Institute
Department
Type
DUNS #
143983562
City
Washington
State
DC
Country
United States
Zip Code
20010
Croarkin, Paul E; Luby, Joan L; Cercy, Kelly et al. (2017) Genetic Risk Score Analysis in Early-Onset Bipolar Disorder. J Clin Psychiatry 78:1337-1343
Stanley, Ian H; Hom, Melanie A; Luby, Joan L et al. (2017) Comorbid sleep disorders and suicide risk among children and adolescents with bipolar disorder. J Psychiatr Res 95:54-59
Salpekar, Jay A; Joshi, Paramjit T; Axelson, David A et al. (2015) Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study. J Am Acad Child Adolesc Psychiatry 54:999-1007.e4
Nassan, Malik; Croarkin, Paul E; Luby, Joan L et al. (2015) Association of brain-derived neurotrophic factor (BDNF) Val66Met polymorphism with early-onset bipolar disorder. Bipolar Disord 17:645-52
Walkup, John T; Wagner, Karen Dineen; Miller, Leslie et al. (2015) Treatment of Early-Age Mania: Outcomes for Partial and Nonresponders to Initial Treatment. J Am Acad Child Adolesc Psychiatry 54:1008-19
Geller, Barbara; Luby, Joan L; Joshi, Paramjit et al. (2012) A randomized controlled trial of risperidone, lithium, or divalproex sodium for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents. Arch Gen Psychiatry 69:515-28
Vitiello, Benedetto; Riddle, Mark A; Yenokyan, Gayane et al. (2012) Treatment moderators and predictors of outcome in the Treatment of Early Age Mania (TEAM) study. J Am Acad Child Adolesc Psychiatry 51:867-78