Prevention of Recurrence in Depression with Drugs and Cognitive Therapy

描述（由申请人提供）：通常认为，抗抑郁药物（ADM）和心理治疗的组合在治疗抑郁症方面比单独治疗更有效。有证据表明，增加认知疗法（CT）增强ADM的初始效果，但大多数相关研究都受到低功率。许多研究的结果也表明，CT具有持久的效果，但大多数证据都与预防复发有关-与治疗事件相关的症状复发。几乎没有证据表明更关键的预防问题：是否事先暴露于CT预防复发-新发作的开始。我们需要的是一项研究，有足够的力量来检测可能伴随着CT加入ADM的好处，并可以解决随之而来的成本效益问题。在过去的几年中，我们随机选择了450例抑郁症门诊患者（三个中心各150例），分别接受ADM单药治疗或ADM加CT治疗。根据临床指征，所有患者均接受最多四种不同类型的抗抑郁药物加增强治疗，直至缓解，然后恢复（每个阶段允许长达18个月）。随机一半的患者除了接受药物治疗外还接受CT检查。然后将恢复的患者随机分配到维持药物组或停药组;合并条件下的患者退出正在进行的CT。然后对患者进行为期三年的随访，以检测复发。主要假设是：（1）相对于单独ADM，联合治疗的缓解率和恢复率将更高;和（2）先前暴露于CT将防止停药后复发。在这一点上，摄入量是完全的，450名患者已被随机治疗。估计的缓解率（所有分配的75%）和恢复率（达到缓解的83%）一直很高，迄今已有150多名恢复患者进入维持期。这项试验的完成将允许对缓解、恢复和复发方面的治疗效果进行强有力的测试，以及探索潜在机制（调解）和通过治疗相互作用（调节）划分患者类型，可用于完善治疗指南。

DESCRIPTION (provided by applicant): It is commonly believed that the combination of antidepressant medications (ADM) and psychotherapy is more efficacious in the treatment of depression than either treatment alone. There is evidence that adding cognitive therapy (CT) enhances the initial effects of ADM, but most of the relevant studies have suffered from low power. Findings from numerous studies also suggest that CT has an enduring effect, but most of the evidence has been relevant to the prevention of relapse - the return of symptoms associated with the treated episode. There is little evidence on the more critical prevention question: whether prior exposure to CT prevents recurrence - the onset of new episodes. What is needed is a study with power sufficient to detect the benefits that might accompany the addition of CT to ADM, and that can address the attendant cost-effectiveness questions. Over the last few years we have randomized 450 depressed outpatients (150 at each of three sites) to ADM alone or to ADM plus CT. All patients are treated to remission and then to recovery (allowing up to 18 months in each phase) with up to four different classes of antidepressant medications plus augmentation, as clinically indicated. A random half of the patients receive CT in addition to medications. Recovered patients are then assigned randomly to either maintenance medications or medication withdrawal; patients in the combined condition are withdrawn from ongoing CT. Patients are then followed for a three-year period for the purpose of detecting recurrences. The main hypotheses are that: (1) rates of remission and recovery will be higher in the combined treatment relative to ADM alone; and (2) prior exposure to CT will protect against recurrence following medication withdrawal. At this point, intake is complete, and 450 patients have been randomized to treatment. Estimated rates of remission (75% of all assigned) and recovery (83% of those who reach remission) have been strong, and over 150 recovered patients have entered the maintenance phase to date. Completion of this trial will allow for powerful tests of treatment effects with respect to remission, recovery, and recurrence, as well as the exploration of underlying mechanisms (mediation) and the delineation of patient-type by treatment interactions (moderation) that can be used to refine treatment guidelines.