Complex Trials for Severe Geriatric Mood Disorders

描述（由候选人提供）：这是在以患者为导向的研究中重新提交K24职业中期研究者奖的申请。这位候选人是匹兹堡大学精神病学终身副教授，拥有临床研究人员和导师的良好记录，致力于改善晚年严重情绪障碍的治疗。 职业发展计划将允许候选人：（1）提高设计，实施和领导大型多中心试验的能力，这些试验主要针对患有严重情绪障碍的老年患者（例如，精神病性抑郁症或双相情感障碍）;（2）发展他在如何提高老年抑郁症非裔美国人参与这些对照试验方面的专业知识;（3）提高他的指导技能以及招募和指导代表性不足的少数民族学员的能力。这些目标将通过课程，讲习班，研讨会和指导阅读或辅导与高级顾问相结合来实现。 Mentorinq计划的目标是希望学习设计和进行晚年情绪障碍干预试验的初级研究人员。在候选人的监督下，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，以及编写用于演示和出版的科学报告来获得实践经验。高级学员还将接受指导，发展自己的独立试点研究和准备入门级K奖。所有受训人员都将接受负责任地进行研究的指导。 该研究计划的重点是精神病性重性抑郁症（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相关的严重疾病。基于候选人和合作研究者的发现，这项资助研究的主要目的是改善精神病性抑郁症的药物治疗，并测试老年精神病性抑郁症患者对药物治疗的耐受性或反应是否低于年轻患者。在该奖项的支持下，本申请中提出的其他工作将侧重于改善本试验和其他试验中患有严重情绪障碍的老年少数民族受试者的招募和保留。

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.