TREATMENT REFRACTORY PANIC DISORDER

这是一个以患者为导向的研究职业发展奖的申请者，重点是发展治疗难治性惊恐障碍研究的专业知识。这位候选人建议以她研究治疗恐慌症的新疗法的专业知识为基础，并接受培训，以评估针对尽管最初干预仍有症状的患者的“下一步”心理药理学和认知行为治疗方法。伴或不伴广场恐惧症的恐慌症是一种常见的焦虑症，当使用包括恐慌症发作、预测性焦虑、广场恐惧症回避以及功能和生活质量测量在内的更广泛的评估缓解措施时，很明显，许多患者仍然有症状，尽管进行了初步治疗，但仍严重受损。然而，指导临床医生治疗这些患者的数据很少，而拟议的研究被设计为以系统的方式解决这一问题的第一步。研究计划：初步研究是一项为期24周的三阶段临床试验，在一个阶段结束时仍有症状的患者进入下一个阶段。第一阶段是一项为期六周的开放舍曲林治疗试验，以前瞻性地确定治疗的难治性。第二阶段是一项为期六周的双盲三臂随机试验，分别为持续剂量舍曲林、增加剂量舍曲林和舍曲林加氯硝西潘。第三阶段是一项为期12周的随机单盲试验，将认知-行为疗法与舍曲林和氯硝西潘的“用药优化”相比较。环境：拟议的研究将在马萨诸塞州综合医院进行，并将补充马克·波拉克博士的指导下的培训和监督研究计划，并征求专家的意见。职业发展计划：培训将强调设计和实施研究所需的技能，以评估对尽管最初干预仍有症状的恐慌症患者的治疗干预措施，培训将包括在哈佛公共卫生学院从事研究方法和统计方面的工作，以及与顾问一起监督结果评估培训、认知行为治疗培训，以及研究将关于恐慌治疗的结果传输到初级保健和社区环境的策略，这将为候选人未来在这一领域的独立调查奠定基础。

This is an application for a Mentored Patient-Oriented Research Career Development Award with a focus on developing expertise in the study of treatment refractory panic disorder. The candidate proposes to build upon her expertise studying novel therapeutics for panic disorder, and obtain training to assess "next-step" psychopharmacologic and cognitive-behavioral therapy approaches for patients who remain symptomatic despite initial intervention. Panic disorder with or without agoraphobia is a common anxiety disorder, and when broader measures assessing remission including panic attacks, anticipatory anxiety, agoraphobic avoidance, and functional and quality of life measures are used, it is clear that many patients remain symptomatic and significantly impaired despite initial treatment. However, there is minimal data to guide clinicians in their approach to these patients, and the proposed study is designed as an initial step in addressing this issue in a systematic manner. Research Plan: The primary study is a three phase, twenty-four week clinical trial in which patients who remain symptomatic at the end of one phase enter the next. Phase I is a six-week open sertraline treatment trial to prospectively determine treatment refractoriness. Phase II is a six-week double-blind three arm randomized trial of sertraline at continued dose, sertraline at elevated dose, and sertraline plus clonazepam. Phase III is a twelve-week randomized single-blind trial of the addition of cognitive-behavioral therapy versus "medication optimization" with sertraline and clonazepam. Environment: The proposed study will be based at the Massachusetts General Hospital and will complement a program of training and supervised research under the mentorship of Dr. Mark Pollack, with consultation from experts. Career Development Plan: Training will emphasize skills necessary for designing and carrying out studies to evaluate treatment interventions for patients with panic disorder who remain symptomatic despite initial intervention, and will include work at the Harvard School of Public Health on research methodology and statistics, and supervision with consultants regarding training in outcome assessment, cognitive-behavioral therapy training, and strategies to study the transmission of findings regarding panic treatment to primary care and community settings that will lay the foundation for future independent investigation by the candidate in this area.