TREATMENT REFRACTORY PANIC DISORDER

这是一份申请以指导病人为导向的研究职业发展奖，重点是在治疗难治性恐慌障碍的研究中发展专业知识。候选人建议以她的专业知识为基础，研究惊恐障碍的新疗法，并获得培训，以评估“下一步”精神药理学和认知行为治疗方法，用于那些尽管初步干预仍有症状的患者。伴有或不伴有广场恐怖症的惊恐障碍是一种常见的焦虑症，当使用更广泛的评估缓解的方法，包括惊恐发作、预期性焦虑、广场恐怖症回避、功能和生活质量测量时，很明显，尽管进行了初步治疗，但许多患者仍有症状并明显受损。然而，很少有数据来指导临床医生对这些患者的治疗方法，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：初步研究是一个为期24周的三期临床试验，在一个阶段结束时仍有症状的患者进入下一个阶段。I期是一项为期6周的开放舍曲林治疗试验，以前瞻性地确定治疗的难治性。II期是一项为期6周的双盲三组随机试验，包括持续剂量的舍曲林、升高剂量的舍曲林和舍曲林加氯硝西泮。第三阶段是一项为期12周的随机单盲试验，对认知行为疗法与舍曲林和氯硝西泮的“药物优化”进行对比。环境：拟议的研究将以马萨诸塞州总医院为基础，并将补充Mark Pollack博士指导下的培训和监督研究计划，并征求专家意见。职业发展规划：培训将强调设计和实施研究所需的技能，以评估对最初干预后仍有症状的恐慌症患者的治疗干预措施，并将包括在哈佛公共卫生学院的研究方法和统计工作，以及与顾问一起监督结果评估培训，认知行为治疗培训，以及研究将有关恐慌治疗的发现传播到初级保健和社区环境的策略，这将为候选人在该领域的未来独立调查奠定基础。

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.