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，并在理事会2001年1月18日的会议上批准提交。这两个目的是：(1)调查药物对患有BP-1(躁狂期或混合期)或躁狂症的儿童和青少年的疗效。(2)试行复杂、多层次、适应性的战略设计。基于设计的新颖性和对大样本规模(因此昂贵)的需要，申请人被要求只提交五年计划头两年的议定书。如果头两年成功实施，将寻求为后三年提供资金。 为了清楚起见，该提案是针对整个五年编写的，尽管预算仅限于头两年。因此，该研究计划规定对540名患有DSM BP-1(躁狂期或混合期)或躁狂症的6.0-14.11岁的受试者进行检查。 这个协作R01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地点是华盛顿大学，圣路易斯，派：芭芭拉·盖勒，医学博士。数据收集的六个地点是：(1)乔治·华盛顿大学，华盛顿特区，派：帕拉吉特·乔希，医学博士。(2)约翰霍普金斯医学研究所，巴尔的摩，派：约翰·沃库普，医学博士。(3)匹兹堡大学，西方精神病研究所和诊所，派：大卫·阿克塞尔森，医学博士。(4)德克萨斯大学，达拉斯，派：德克萨斯大学格雷厄姆·埃姆斯利，医学博士。(5)德克萨斯大学，加尔维斯顿，派：凯伦·迪宁·瓦格纳，医学博士；(6)华盛顿大学，圣路易斯，派；琼·卢比，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 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.