Treatment of Early Age Mania (TEAM)

描述（由申请人提供）：本提案是与NIMH计划工作人员合作制定的，并在2001年1月18日的理事会会议上批准提交。这两个目的是：（1）研究药物治疗BP-1（躁狂或混合期）或躁狂儿童和青少年的有效性。(2)引导一个复杂的、多层次的、适应性的战略设计。基于设计的新奇和对大样本量（因此成本高）的需求，要求申请人仅提交五年计划前两年的方案。如果头两年的工作顺利进行，将为另外三年寻求资金。 为清楚起见，提案是针对整个五年编写的，尽管预算仅限于头两年。因此，研究计划规定检查540名年龄6.0-14.11岁的DSM BP-1（躁狂或混合期）或躁狂受试者。 U 01的结构是一个协调站点和六个数据收集站点。数据管理和分析以及培训的协调中心是华盛顿大学圣路易斯分校，PI：Barbara Geller，M.D.。收集数据的六个地点是：（1）乔治华盛顿大学，华盛顿，华盛顿特区，PI：Paramjit Joshi，医学博士(2)约翰霍普金斯医学研究所，巴尔的摩，PI：约翰沃克普，医学博士。(3)匹兹堡大学，西部精神病研究所和诊所，PI：大卫阿克塞尔森，医学博士。(4)德克萨斯大学，达拉斯，PI：Graham Emslie，医学博士(5)德克萨斯大学，加尔维斯顿，PI：Karen Dineen瓦格纳，医学博士。和（6）华盛顿大学，圣路易斯，PI;琼吕比，医学博士。

DESCRIPTION (provided by applicant): 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 U01 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.