Complex Trials for Severe Geriatric Mood Disorders

描述(由候选人提供)：这是以患者为中心的研究中K24职业中期调查员奖的重新提交的申请。这位候选人是匹兹堡大学的终身精神病学副教授，有临床研究和导师的既定记录-致力于改善晚年严重情绪障碍的治疗。 职业发展计划将使候选人能够：(1)增强设计、实施和领导以严重情绪障碍(如精神病抑郁或双相情感障碍)老年患者为重点的大型多中心试验的能力；(2)发展有关如何提高老年抑郁症非裔美国人参与这些对照试验的专门知识；(3)提高指导技能以及招募和指导代表不足的少数族裔受训者的能力。这些目标将通过课程、讲习班、研讨会以及与高级顾问的指导阅读或辅导相结合的方式实现。 Mentorinq计划针对的是那些想要学习设计和进行老年情绪障碍干预试验的初学者。在候选人的指导下，学员将通过对参与正在进行的临床试验的患者进行研究评估，参与多学科招募、方案管理和数据会议，以及准备科学报告以供提交和发表，来获得实践经验。高级受训人员还将在发展自己的独立试点研究和准备入门级K奖项方面得到指导。所有受训人员都将接受负责任的研究指导。 该研究计划侧重于精神病性重度抑郁(PMD)的药物治疗，PMD是一种与自杀、严重功能障碍和抗抑郁治疗抵抗有关的严重障碍。基于候选人和合作研究人员的发现，这项资助研究的主要目的是改善精神病抑郁的药物治疗，并测试老年精神病抑郁患者是否比年轻患者对药物治疗的耐受性或反应减弱。在这一奖项的支持下，这项申请中提议的额外工作将集中在改善在这项试验和其他试验中招募和保留患有严重情绪障碍的老年少数族裔受试者。

DESCRIPTION (provided by candidate): This is the resubmission of an application for a K24 Midcareer Investigator Award in patient-oriented research. The candidate -- a tenured Associate Professor of Psychiatry at the University of Pittsburgh with an established record as a clinical researcher and mentor-- is dedicated to improving the treatment of severe mood disorders in late-life. The Career Development Plan will allow the candidate to: (1) enhance his ability to design, implement, and lead large multicenter trials focused on older patients with severe mood disorders (e.g., with psychotic depression or with bipolar disorder); (2) develop his expertise on how to improve participation of older depressed African Americans in these controlled trials; (3) improve his mentoring skills and his ability to recruit and mentor underrepresented minority trainees. These objectives will be reached through a combination of courses, workshops, seminars, and directed readings or tutorials with senior consultants. The Mentorinq Plan is targeted towards beginning investigators who want to learn to design and conduct intervention trials for late-life mood disorders. Under supervision by the candidate, trainees will obtain hands-on experience by conducting research assessments of patients participating in ongoing clinical trials, participating in multidisciplinary recruitment, protocol management, and data meetings, and by preparing scientific reports for presentation and publication. Advanced trainees will also be mentored in the development of their own independent pilot studies and preparation of entry-level K awards. All trainees will receive instruction in the responsible conduct of research. The Research Plan is focused on the pharmacologic treatment of psychotic major depression (PMD), a severe disorder that is associated with suicide, severe functional impairment, and resistance to antidepressant treatment. Building on findings from the candidate and collaborating investigators, the primary aims of this funded study are to improve the pharmacologic treatment of psychotic depression and to test whether older patients with psychotic depression have a diminished tolerance or response to pharmacologic treatment than younger patients. With the support of this award, additional work proposed in this application will focus on improving recruitment and retention of older minority subjects with severe mood disorders in this and other trials.