Treatment of Early Age Mania (TEAM)

描述（由申请人提供）：该提案是与 NIMH 计划工作人员合作制定的，并由理事会在 2001 年 1 月 18 日的会议上批准提交。这两个目的是：(1) 调查药物治疗对患有 BP-1（躁狂或混合期）或躁狂的儿童和青少年的有效性。 (2) 试点复杂的、多层次的、适应性的策略设计。基于设计的新颖性以及对大量（因此成本高昂）样本量的需求，申请人被要求仅提交五年计划前两年的方案。如果前两年成功实施，将寻求额外三年的资金。 为了清楚起见，该提案是针对整个五年编写的，尽管预算仅限于前两年。因此，该研究计划对 540 名年龄为 6.0-14.11 岁、患有 DSM BP-1（躁狂或混合期）或躁狂症的受试者进行检查。 该协作R01的结构是1个协调站点和6个数据收集站点。负责数据管理、分析和培训的协调站点是华盛顿大学，圣路易斯，PI：Barbara Geller，医学博士。六个数据收集站点是：(1) 乔治华盛顿大学，华盛顿特区，PI：Paramjit Joshi，医学博士 (2) 约翰·霍普金斯医疗机构，巴尔的摩，PI：John walkup，医学博士 (3) 匹兹堡大学，西安大略大学精神病学研究所和诊所，PI：David Axelson，医学博士 (4) 德克萨斯大学达拉斯分校，PI：Graham Emslie，医学博士 (5) 德克萨斯大学加尔维斯顿分校，PI：Karen Dineen Wagner，医学博士和 (6) 华盛顿大学，圣路易斯，PI；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.