Long-term antidepressant outcome in bipolar depression

双相抑郁症的长期抗抑郁治疗结果

• 批准号: 6708085
• 负责人: Nassir GHAEMI
• 金额: $ 16.49万
• 依托单位: CAMBRIDGE HEALTH ALLIANCE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-02-10 至 2006-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6708085
• 关键词: antidepressants; bipolar depression; clinical trials; drug adverse effect; drug screening /evaluation; human morbidity; human subject; human therapy evaluation; iatrogenic disease; longitudinal human study; mental disorder chemotherapy; mental disorder diagnosis; neuropharmacology; outcomes research; patient oriented research; statistics /biometry

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.

描述（改编自申请人的摘要）：摘要：这是一个 申请 NIMH 指导的以患者为导向的研究职业发展 奖励（K-23）以培养评估、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 research experiences.申请人将研究继续与终止的影响。 以自然但受控和随机的方式停用抗抑郁药， 针对双相情感障碍患者的长期（长达 3 年）临床研究 临床上维持情绪稳定治疗。该提案将是 作为 NIMH 资助的国家系统治疗的一部分完成 双相情感障碍增强计划 (STEP-BD) 项目。 理由：与单相重性抑郁症相比，双相抑郁症是 是研究最少的抑郁症之一，对抑郁症的研究很少 与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病程的影响， 包括诱发躁狂、混合状态、精神病或快速循环。 尽管有这些潜在的风险，双相情感障碍的抑郁期仍然是 临床上足以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 混乱，支持当前提案的时间表。未知是否 这些抗抑郁治疗在这些方面是有效的，甚至是安全的 情况。 环境：该项目基于麻省总医院项目 NIMH 国家双相情感障碍长期治疗 STEP-BD 研究中心 障碍，与另外两个 STEP-BD 网站合作。 Included are a 主要指导下的实践培训和监督研究计划 Ross J. Bladessarni 医学博士、Gary S. Sachs 医学博士共同发起以及咨询 作者：双相情感障碍专家 Frederick K. Goodwin（医学博士）和生物统计学家 John Hennen PhD. 职业发展计划：培训旨在假设申请人 achieves competence in the critical evaluation and design of long-term 对患有严重情感障碍的成人以及在 将这些技能应用于受监督的设计、实施和分析 临床试验。培训包括完成哈佛大学的公共卫生硕士课程 公共卫生学院和研究理论与分析教程 纵向研究的设计和统计方法由 生物统计顾问与导师、共同发起人和 顾问。在此过程中，申请人将发展领导能力 双相情感障碍长期治疗的独立研究 principal investigator.