Prevention of Recurrence in Depression with Drugs and CT

描述(申请人提供)：人们普遍认为，抗抑郁药物(ADM)和心理疗法的结合在治疗抑郁症方面比单独使用任何一种治疗方法都更有效。有证据表明，加用认知疗法(CT)可以增强ADM的初始疗效，但大多数相关研究都存在效率低下的问题。大量研究的结果也表明，CT具有持久的效果，但大多数证据都与预防复发有关--与治疗后的发作相关的症状的复发。在更关键的预防问题上，几乎没有证据：事先接触CT是否可以防止复发--新发作的发生。需要的是一项研究，具有足够的力量来检测在ADM中添加CT可能带来的好处，并能够解决随之而来的成本效益问题。在过去的几年里，我们将450名抑郁症患者(三个地点各150名)随机分为ADM组或ADM加CT组。所有患者都接受缓解治疗，然后恢复(每个阶段允许长达18个月)，临床表明，最多使用四种不同类别的抗抑郁药物加增强治疗。随机抽取一半的患者在接受药物治疗的同时接受CT检查。然后，康复的患者被随机分配到维持性药物或停药组；合并情况的患者被取消正在进行的CT检查。然后对患者进行为期三年的跟踪调查，以检测复发情况。主要假设是：(1)与单用ADM相比，联合治疗的缓解率和恢复率更高；(2)事先接触CT将防止停药后复发。在这一点上，摄入已经完成，450名患者已经被随机分配到治疗中。估计缓解率(占分配总数的75%)和恢复率(达到缓解者的83%)一直很高，迄今已有150多名康复患者进入维持阶段。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，并探索潜在的机制(调解)，并通过治疗互动(缓和)确定可用于完善治疗指南的患者类型。

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assigned randomly to either maintenance medications or medication withdrawal; patients in the combined condition are withdrawn from ongoing CT.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.