Treatment of Early Age Mania (TEAM)

早期躁狂症的治疗（TEAM）

• 批准号: 7085502
• 负责人: PARAMJIT T. JOSHI
• 金额: $ 41.19万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7085502
• 关键词: adolescence (12-20); antidepressants; behavioral /social science research tag; bipolar depression; bipolar depression manic phase; chlorpromazine; clinical research; combination therapy; cooperative study; disease /disorder onset; human subject; human therapy evaluation; mental disorder chemotherapy; middle childhood (6-11); patient oriented research; psychopharmacology; therapy compliance

DESCRIPTION (provided by applicant): Childhood bipolar disorder (BP-I) is a chronic illness that seriously impairs home, school and peer functioning and is associated with high rates of psychosis, mixed mania, ultradian rapid cycling and suicidality. Even bright children get failing grades at school and most require a myriad of medications. Given the newness of recognizing the existence of child BP, there is as yet scant knowledge of treatment, including whether medications that have shown effectiveness in adult BP will have similar effects in children. Regarding treatment, two of the more pressing issues have been (1) which class of drug to use first (lithium, valproate, atypical neuroleptics) and (2) which drug to add-on or switch to if the first drug fails. To investigate these research questions, the TEAM project was initiated two years ago as a complex, multi-site, multi-strata, equipoise stratification, adaptive strategy design to study 540 subjects with child BP-I (manic or mixed phase), aged 6-15. In this paradigm, subjects are randomized within three strata that include Stratum One for those on no study medications. Stratum Two is an add-on strategy for those who are partial responders to one study drug. Stratum Three is a cross-taper strategy for those who have failed one study medication. Also, subjects who are partial or poor responders in Stratum One are re-randomized to the other two strata. Due to the novelty and cost of this design, NIMH requested that TEAM begin as a two year pilot, with the proviso that if the two year pilot demonstrated feasibility, the investigators would be encouraged to apply for an additional four years of funding to complete the study. At the time of this writing (5/27/04 for a 6/7/04 submission date), there are 107 randomized subjects, which exceeds the planned recruitment rate. Furthermore, all three strata are being filled. Therefore, feasibility has been established. As a large cooperative agreement, this study is monitored on a quarterly basis by the NIMH Data and Safety Monitoring Board (DSMB). At the five DSMB audits conducted at the time of this writing, TEAM has received outstanding praise for data management, quality control, and safety. The structure of this cooperative agreement is one coordinating site (Washington U in St. Louis, PI: B. Geller) and five data collection sites (Children's National Medical Center, PI: P. Joshi; Johns Hopkins Medical Institutions, PI: J. Walkup; U Pittsburgh, PI: D. Axelson; UT Medical Branch, Galveston, PI: K. Dineen Wagner; Washington U in St. Louis, PI: J. Luby). Dr. Ben Vitiello is the NIMH scientific collaborator. The chief study statistician, Dr. Satish lyengar is subcontracted to the coordinating site at Washington U in St. Louis and Dr. Philip Lavori is a major consultant for statistical analyses.

描述（由申请人提供）：儿童期躁郁症（BP-I）是一种慢性疾病，严重损害家庭，学校和同伴的功能，并与高精神病，混合躁狂症，超级快速骑自行车和自杀率有关。甚至聪明的孩子在学校的成绩失败，大多数人都需要无数的药物。鉴于认识到儿童BP存在的新颖性，尚未了解治疗的知识，包括在成年BP中表现出有效性的药物是否会对儿童产生相似的影响。关于治疗，有两个更紧迫的问题是（1）首先使用哪种药物（锂，丙戊酸，非典型神经摄影）和（2）（2）如果第一种药物失败，则使用哪种药物或转为使用。为了调查这些研究问题，团队项目是两年前作为一个复杂的，多站点的，多条纹的，平气分层的，自适应策略设计，研究540名儿童BP-I（躁狂或混合阶段），年龄6-15岁。在此范式中，受试者是在三个层中随机分配的，其中包括一个没有研究药物的人。对于那些对一种研究药物的部分响应者来说，阶层二是一个附加策略。对于那些未通过一种研究药物的人来说，第三层是一种跨钳策略。同样，一个阶层中的局部反应者或较差的受试者也将其重新融合到其他两个阶层。由于这种设计的新颖性和成本，NIMH要求团队以两年的飞行员开头，而Proviso则说，如果两年的飞行员证明了可行性，则将鼓励调查人员申请另外四年的资金来完成这项研究。在撰写本文时（04/04/04提交日期为5/27），有107个随机受试者，超过了计划的招聘率。此外，所有三个阶层都被填满了。因此，已经建立了可行性。作为一项庞大的合作协议，NIMH数据和安全监测委员会（DSMB）对这项研究进行了季度监控。在撰写本文时进行的五项DSMB审核中，团队对数据管理，质量控制和安全性获得了杰出的赞誉。这项合作协议的结构是一个协调的站点（圣路易斯的华盛顿U，PI：B。Geller）和五个数据收集站点（儿童医疗中心，PI：P。Joshi; Johns Hopkins医疗机构，PI：J。Walkup； J. Walkup; J. Walkup; Pi; pi pi; u pi pi：D。Axelson; D. Axelson; D. Axelson; D. Axelson; ut Medical Branch; ut Medical Branch，piis louis pi：K. Luby）。 Ben Vitiello博士是NIMH科学合作者。首席研究统计学家Satish Lyengar博士分包到圣路易斯华盛顿U的协调地点，Philip Lavori博士是统计分析的主要顾问。