TREATMENT OF PANIC DISORDER--LONG TERM STRATEGIES

这是一项多中心研究的四个相同应用之一 惊恐障碍(PD)的长期治疗策略。该研究建立了 根据我们最初的多中心研究比较的结果 丙咪嗪、安慰剂、认知行为疗法(CBT)及其 联合治疗不超过轻度帕金森病的患者 广场恐惧症。该研究发现，使用CBT或 丙咪嗪单独使用，如它们的组合。考虑到增加了 综合治疗，因此从一开始似乎是合理的 单一疗法。此外，遵循医疗实践的一般原则， 对侵袭性较小的患者开始治疗是合理的。 行为干预。因此，重要的是要了解应该是什么 在最初的治疗之后完成。拟议的拨款解决了这一问题 主题。 在拟议的研究中，所有受试者最初都只接受CBT。 然后，受试者在两项急性发作后研究中的一项中随机进行，具体取决于 处于响应状态。这些研究涉及两个问题：(1) 对CBT初始疗程有反应的患者，是维持治疗 是否需要维持回应？；及(2)在未能回应的人士中 基本上是CBT的初始课程，将增加 药物治疗能改善反应吗？总共336个科目将是 在3年的时间里从4个网站注册。响应者将是 随机进行维护研究，比较不维护和9个月的维护 继续进行CBT。无反应者将随机参加一项研究 帕罗西汀与持续CBT的比较。除了主要的 问题，可能的反应和复发的预测因素将被检查 以及可能的反应调解人。 这项提议的核心是继续一个运作良好和 进行当前研究的站点之间的富有成效的协作。 这些网站已经有了经过培训和认证的评估 以及治疗人员和严格的监测程序 对于进行我们所提议的研究来说是必不可少的。

This is one of four identical applications for a multi-center study of long-term treatment strategies for panic disorder (PD). The study builds upon the findings of our original multi-center study comparing imipramine, placebo, cognitive behavior therapy (CBT), and their combination in the treatment of PD patients with no more than mild agoraphobia. That study found response rates were as high with CBT or imipramine alone as with their combination. Given the added cost of combined treatments, it therefore seems reasonable to begin with monotherapy. Further, following general principles of medical practice, it would be reasonable to initiate treatment with the less invasive behavioral intervention. It is then important to learn what should be done following initial treatment. The proposed grant addresses this subject. In the proposed study, all subjects initially receive CBT alone. Subjects are then randomized in one of two postacute studies, depending on response status. These studies address two questions: (1) among patients who respond to an initial course of CBT, is maintenance therapy required to maintain response?; and (2) among those who fail to respond substantially to an initial course of CBT, will the addition of pharmacotherapy improve response? A total of 336 subjects will be enrolled from 4 sites over a 3 year period. Responders will be randomized to a maintenance study comparing no maintenance with 9 months of continued CBT. Non-responders will be randomized to a study comparing paroxetine with continued CBT. In addition to the main questions, possible predictors of response and relapse will be examined as well as possible mediators of response. Central to this proposal is the continuation of a well-functioning and productive collaboration among the sites conducting the current study. These sites already have in place the trained and certified assessment and treatment personnel and rigorous monitoring procedures that are essential for the conduct of a study such as the one we propose.