MULTICTR COMPARATIVE TREATMENT STUDY OF PANIC DISORDER

三个广泛的目标构成了多中心继续申请的基础。 治疗惊恐障碍的合作研究; 1）完成 最初提出的研究，比较认知行为恐慌控制 治疗（PCT），丙咪嗪或安慰剂给药双盲（MED）， 组合（COM），2）6或24以上的治疗持久性比较 维持1个月，再随访24个月，和3）交叉 MED和PCT对相反治疗无应答者的治疗。 完成480人中剩余37%的入组显然很重要 患者需要回答与相对疗效相关的关键问题， PCT、MED和COM。 研究招募开始的时间比我们预计的要晚一些 由于严格关注最先进的评估和质量， 控制程序。 仔细思考基本的评估领域 似乎很值得你这么做 我们不仅需要 开发工作很好，但他们已经被其他人使用 该领域的研究人员，并影响了最近的共识， 惊恐障碍的评估 我们非常重视培训， 认证治疗师和发展广泛的质量保证 程序，对跨中心研究至关重要。 PCT遵守评级为 其中最详细和严格的领域，而我们的程序， MED培训、认证和依从性监测反映了 在精神药理学试验中很少进行质量控制。 长期维护和随访的研究是一个自然和重要的 有效性研究的扩展。 短期治疗效果， 恐慌症已经确立，人们越来越认识到需要 以解决治疗的持久性，特别是药物。 自然主义 参与疗效试验的患者随访文件 持续的间歇性症状和持续的功能障碍， 持续的自然主义治疗，以及高复发率， 停药。 然而，目前还没有关于 使用严格的盲法评估程序和质量的长期结局 控制性维持治疗。 有必要确定路线， 在最佳长期维持治疗期间和之后的结果。 虽然 这是一个明显的问题，迄今为止很少有研究调查 序贯治疗策略。 这些方法可以提供 相当有用的信息。 我们最初的研究将为临床医生提供明确的信息 关于惊恐障碍急性治疗的最佳选择 我们现在 认识到，我们收集的一批受试者也提供了一个 进行第一次大规模治疗研究的独特机会 耐久性和第一次系统研究的有效性交叉 治疗无反应者。 因此，我们建议增加这些目标。

Three broad goals underlie this continuation application for a multicenter collaborative study of the treatment of panic disorder; 1) completion of the originally proposed study, comparing cognitive behavioral panic control treatment (PCT), imipramine or placebo administered double blind (MED) and the combination (COM), 2) comparison of treatment durability over 6 or 24 month maintenance with further 24 month follow-up, and 3) cross-over treatment of MED and PCT nonresponders to the opposite treatment. It is clearly important to complete enrollment of the remaining 37% of 480 patients needed to answer key questions related tot he relative efficacy of PCT, MED and COM. Study enrollment began somewhat later than we predicted because of rigorous attention to state-of-the -art assessment and quality control procedures. Careful thought about essential assessment domains appears to have been well worth the effort. Not only are the procedures we developed working well, but they have been used already by other investigators in the field and have influenced recent consensus on assessment of panic disorder. We devoted great care to training and certifying therapists and to developing extensive quality assurance procedures, essential to a cross site study. PCT adherence ratings are among the most detailed and rigorous in the field, while our procedures for MED training, certification and adherence monitoring reflect a level of quality control rarely undertaken in psychopharmacology trials. Study of long term maintenance and follow-up is a natural and important extension of the efficacy study. With efficacy of short term treatment for panic disorder well established, there is growing recognition of the need to address durability of treatment, especially medication. Naturalistic follow-up of patients who participated in efficacy trials document continued intermittent symptoms and ongoing functional impairment even with continued naturalistic treatment, and a high rate of relapse following medication discontinuation. However, there ar no prospective studies of long term outcome using rigorous, blinded assessment procedures and quality controlled maintenance treatment. There is a need to determine course and outcome during and after optimal long term maintenance treatment. Although this is an obvious question, few studies to date have investigated sequential treatment strategies. Such approaches could provide considerable useful information. Our original study will provide definitive information for clinicians regarding the best choices for acute treatment of panic disorder. We now recognize that the cohort of subjects we have assembled also provide a unique opportunity to conduct the first large scale study of treatment durability and the first systematic study of effectiveness of cross-over treatment for nonresponders. Thus, we are proposing to add these aims.