RUPP-PI

描述(由申请人提供)：本申请是针对国家精神卫生研究所提出的建立精神药理学和心理社会干预研究单位的申请。该应用基于我们调查小组的专业知识和我们在多地点研究方面的经验，特别是NIH资助的多地点精神药理学和心理社会干预研究。我们有提供领导力和在我们的合作努力中和蔼可亲地共同发挥作用的能力的记录。我们研究小组的科学目标与RUPP-PI的RFA精神高度一致。我们的目标是开发和实施多站点：1)建立新的循证精神药理学和心理社会治疗的疗效研究；2)确定最佳治疗剂量、最佳治疗顺序、合理停止治疗的时间和比较治疗试验的创新疗效研究；3)在学校、儿科诊所和社区精神卫生中心等“现实世界”环境中应用疗效研究结果的有效性研究；4)有效监测精神药物长期安全性的方法。该提案中包含的示范议定书具有独特的公共卫生意义，是可行的、包容的，并按照最高道德标准设计实施。它描述了一项为期5年的多部位、3臂、双盲、安慰剂替代干预，以确定患有严重抑郁障碍的儿童和青少年的最佳抗抑郁治疗长度。

DESCRIPTION (provided by applicant): This application responds to a Request for Applications from the NIMH to establish Research Units of Psychopharmacology and Psychosocial Interventions (RUPP-PI). The application builds on the expertise of our investigative group and our experience with multisite studies, especially NIH funded multisite psychopharmacological and psychosocial intervention studies. We have a track record of providing leadership and the capacity to function amiably and collegially in our collaborative efforts. The Scientific Aims of our research group are highly compatible with the spirit of the RFA for the RUPP-PI. Our goals are to develop and implement multisite: 1) efficacy studies that establish new evidence-based psychopharmacological and psychosocial treatments; 2) innovative efficacy studies that determine the optimal "dose" of treatments, optimal sequence of treatments, rational timing of discontinuation of treatments, and comparative treatment trials; 3) effectiveness studies that apply the results of efficacy studies in "real world" settings, such as schools, pediatric practices, and community mental health centers; 4) methods to effectively monitor long-term safety of psychotropic medications. The exemplar protocol contained in this proposal has unique public health significance, is feasible, inclusive, and designed to be implemented according to the highest ethical standards. It describes a 5-year multisite 3-arm, double blind, placebo substitution intervention to establish the optimal length of antidepressant treatment in children and adolescents with Major Depressive Disorder.