Long-term antidepressant outcome in bipolar depression

描述（改编自申请人的摘要）：概述：这是一个 申请NIMH指导的以患者为导向的研究职业发展 奖项（K-23），以发展评估，设计和应用方面的专业知识 评估双相情感障碍药物治疗的研究方法 抑郁症，基于教学，辅导和实践的平衡计划 研究经验。申请人将研究继续与 在一个自然的，但控制和随机的， 在双相情感障碍患者中进行的长期（长达3年）临床研究， 在临床上一直接受情绪稳定治疗该提案将 作为国家NIMH赞助的系统治疗的一部分完成 双相情感障碍增强计划（STEP-BD）项目。 基本原理：与单相抑郁症相比，双相抑郁症是 是研究得最少的抑郁症之一， 抗抑郁药联合使用的长期疗效或安全性 情绪稳定剂，或其对双相情感障碍过程的影响， 包括躁狂、混合状态、精神病或快速循环的诱导。 尽管有这些潜在的风险，双相情感障碍的抑郁阶段， 在临床上足够有说服力， 情绪稳定剂是双相情感障碍患者最常用的治疗方法。 混乱，支持本提案的时间表。不清楚是否 这些抗抑郁治疗在这些患者中是有效的，甚至是安全的。 情节 环境：该项目基于马萨诸塞州综合医院项目 NIMH国家STEP-BD双相情感障碍长期治疗研究中心 疾病，与其他两个STEP-BD网站的合作。包括一个 初级指导下的实践培训和监督研究计划 由Ross J. Bladessarni医学博士、加里S. Sachs医学博士和咨询 由躁郁症专家弗雷德里克·K·Goodwin医学博士和生物统计学家John Hennen博士 职业发展计划：培训旨在假设申请人 在长期的关键评估和设计方面取得能力 在患有严重情感障碍的成年人中进行的药理学研究，以及 应用这些技能的设计，行为，和分析的监督 临床试验培训包括在哈佛完成公共卫生硕士课程 学校公共卫生辅导课的理论与分析研究 设计和统计方法的纵向研究监督的 生物统计学顾问与导师、共同申办者和 顾问。在这个过程中，申请人将发展领导能力 长期治疗双相情感障碍的独立研究， 首席调查员

DESCRIPTION (Adapted from the Applicant's Abstract):Summary: This is an application for an NIMH Mentored Patient-Oriented Research Career Development Award (K-23) to develop expertise in evaluating, designing and applying research methods for assessing pharmacological treatments for bipolar depression, based on a balanced program of didactic, tutorial, and practical research experiences. The applicant will study the impact of continuing vs. discontinuing antidepressants in a naturalistic, but controlled and randomized, long-term (up to 3 year) clinical study of patients with bipolar disorder who are clinically maintained on mood-stabilizing treatment. The proposal will be completed as part of the national NIMH-sponsored Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) project. Rationale: In contrast to unipolar major depression, bipolar depression is among the least studied depressive illnesses, with very little research on the long-term efficacy or safety of antidepressants used in conjunction with mood-stabilizing agents, or their effect on the course of bipolar disorders, including induction of mania, mixed states, psychosis, or rapid-cycling. Despite these potential risks, the depressive phase of bipolar disorder is sufficiently compelling clinically that antidepressants rather than mood-stabilizing agents are the most commonly used treatments in bipolar disorder, supporting the timelines of the present proposal. It is unknown if these antidepressant treatments are effective or even safe in these circumstances. Environment: The project is based at the Massachusetts General Hospital project site of the NIMH national STEP-BD study of long-term treatment of bipolar disorder, with the collaboration of two other STEP-BD sites. Included are a program of practical training and supervised research under primary mentorship of Ross J. Bladessarni MD, co-sponsorship by Gary S. Sachs MD, and consultation by bipolar disorder expert Frederick K. Goodwin MD and biostatistician John Hennen PhD. Career development plan: Training is designed to assume that the applicant achieves competence in the critical evaluation and design of long-term pharmacological studies in adults with major affective disorders, as well as in applying these skills to the design, conduct, and analysis of a supervised clinical trial. Training includes completion of MPH coursework at the Harvard School of Public Health and tutorials on the theory and analysis of research designs and statistical methods for longitudinal studies supervised by the biostatistical consultant in collaboration with the mentor, co-sponsor, and consultants. In this process, the applicant will develop competence to lead independent studies of the long-term treatment of bipolar disorder as a principal investigator.