Long-term antidepressant outcome in bipolar depression

描述(改编自申请人摘要)：摘要：这是一份 NIMH以患者为导向的研究生涯发展指导计划的申请 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，基于说教、指导和实践的平衡方案 研究经验。申请者将研究继续与 停用抗抑郁药物，这是一种自然主义的，但受控和随机的， 双相情感障碍患者的长期(长达3年)临床研究 在临床上维持稳定情绪的治疗。该提案将是 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。 理论基础：与单相抑郁症相比，双相抑郁是 在研究最少的抑郁性疾病中，很少有关于 联合应用抗抑郁药的长期疗效或安全性 情绪稳定剂，或它们在双相情感障碍病程中的作用， 包括躁狂、混合状态、精神病或快速循环的诱发。 尽管有这些潜在的风险，双相情感障碍的抑郁阶段是 在临床上足够令人信服的是抗抑郁药而不是 情绪稳定剂是双相情感障碍最常用的治疗方法 无序，支持本提案的时间表。目前还不清楚是否 这些抗抑郁药物在这些患者中是有效的，甚至是安全的。 情况。 环境：该项目以马萨诸塞州综合医院项目为基础 NIMH国家STEP-BD双相情感障碍长期治疗研究现场 混乱，与其他两个STEP-BD网站的合作。其中包括一个 初级导师指导下的实践培训和督导研究计划 罗斯·J·布拉德萨尼医学博士，加里·S·萨克斯医学博士共同赞助，以及咨询 双相情感障碍专家弗雷德里克·K·古德温医学博士和生物统计学家约翰 亨南博士。 职业发展计划：培训旨在假定申请者 具备批判性评估和长期设计的能力 对患有严重情感障碍的成年人的药理学研究，以及 将这些技能应用于设计、实施和分析受监督的 临床试验。培训包括在哈佛大学完成公共卫生硕士课程 关于公共卫生学院教程的理论与分析研究 由委员会监督的纵向研究的设计和统计方法 生物统计学顾问，与导师、共同赞助人和 顾问。在这个过程中，申请者将发展领导能力。 双相情感障碍长期治疗的独立研究 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.