Treatment of Early Age Mania (TEAM)

早期躁狂症的治疗（TEAM）

• 批准号: 6658130
• 负责人: BARBARA GELLER
• 金额: $ 77.5万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2005-06-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6658130
• 关键词: adolescence (12-20); age difference; anticonvulsants; antipsychotic agents; bipolar depression; bipolar depression manic phase; child mental disorders; clinical research; clinical trials; combination chemotherapy; cooperative study; cyclothymia; family structure /dynamics; gender difference; human subject; human therapy evaluation; lithium; mental disorder chemotherapy; middle childhood (6-11); parent offspring interaction; patient oriented research; psychotropic drugs; relapse /recurrence; risperidone; therapy compliance; valproate

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.

描述（由申请人提供）：该提案是与NIMH计划人员合作制定的，并在其1/18/01会议上批准了议会提交。这两个目的是：（1）研究患有BP-1（躁狂或混合阶段）或躁狂症的儿童和青少年药物的有效性。 （2）驾驶复杂的多发性，自适应策略设计。根据设计的新颖性以及对大型（且昂贵）样本量的需求，要求申请人仅在五年计划的前两年提交协议。如果成功实施了头两年，将寻求另外三年的资金。 为了清楚起见，该提案是在整个五年中编写的，即使预算仅限于头两年。因此，研究计划规定了患有DSM BP-1（躁狂或混合阶段）或躁狂症的6.0-14.11岁的540名受试者。 该协作U01的结构是一个协调网站和六个数据收集站点。用于数据管理和分析和培训的协调网站是华盛顿大学，PI：Barbara Geller，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，PI：Paramjit Joshi，Paramjit Joshi，M.D。 PI精神病学院和诊所：医学博士David Axelson（4）德克萨斯大学达拉斯大学，PI：Graham Emslie，M.D。（5）德克萨斯大学，德克萨斯大学，加尔维斯顿大学，PI：Karen Dineen Wagner，M.D。and M.D. and（6）华盛顿大学，圣路易斯，PI；琼·卢比（Joan Luby），医学博士