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.
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