Prevention of Recurrence in Depression with Drugs and CT

描述（由申请人提供）：通常认为， 抗抑郁药物（ADM）和心理治疗的组合更多 治疗抑郁症的效果比单独使用任何一种都好。那里 有证据表明，增加认知疗法（CT）可以增强 ADM，但大多数相关的研究都遭受了低功率。此外，委员会认为， 许多研究的结果表明，CT具有持久的效果，但大多数 的证据一直与预防复发-返回的 与治疗事件相关的症状。几乎没有证据表明 可以说是更关键的预防问题： 防止复发-新的发作的开始。我们需要的是一项研究， 足够敏感，可以检测到添加 CT到ADM，这可以开始解决随之而来的成本效益问题 问题.所提出的设计结合了有效性的目标和方法， 为达到这一目的而进行的有效研究。我们计划随机分配450名抑郁症患者 门诊患者（三个站点各150例）单独ADM或ADM加CT。所有 患者将接受具有临床代表性的阿霉素治疗以缓解病情 方案，一半将另外接受CT。康复患者将在 持续用药长达12个月，直到符合以下标准 恢复期，在此期间，将根据临床指征继续进行CT检查， 患者进行综合治疗。一旦康复，患者将被随机 分配给维持药物或停药。不久 此后，已接受CT的患者将退出CT， 好.然后将对患者进行为期三年的随访，目的是 检测复发。主要假设是：（1）初始反应将是 ADM + CT组优于ADM组;（2）CT暴露后， 预防停药后的复发， 与维护ADM相同的程度。将采用分析来估计 在ADM中添加CT治疗急性反应的相对成本效益， 预防复发。

DESCRIPTION (provided by applicant): It is commonly believed that the combination of antidepressant medications (ADM) and psychotherapy is more effective in the treatment of depression than is 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. Moreover, findings from numerous studies 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 what is arguably the more critical prevention question: whether prior exposure to CT prevents recurrence - the onset of new episodes. What is needed is a study that is sensitive enough to detect the benefits that might accompany the addition of CT to ADM, and that can begin to address the attendant cost-effectiveness questions. The proposed design combines the goals and methods of efficacy and effectiveness research to these ends. We plan to randomly assign 450 depressed outpatients (150 at each of three sites) to ADM alone or to ADM plus CT. All patients will be treated to remission with a clinically representative ADM regimen, and half will, in addition, receive CT. Remitted patients will then be continued on medications for up to 12 months until they meet criteria for recovery, during which time CT will be continued as clinically indicated for patients in combined treatment. Once recovered, patients will be randomly assigned to either maintenance medications or medication withdrawal. Shortly thereafter, patients who have been receiving CT will be withdrawn from it as well. Patients will then be followed for a three-year period for the purpose of detecting recurrences. The main hypotheses are: (1) initial response will be better in ADM plus CT, relative to ADM alone; and (2) prior exposure to CT will protect against subsequent recurrence following medication withdrawal, to the same extent as maintenance ADM. Analyses will be employed to estimate the relative cost-effectiveness of adding CT to ADM for acute response and recurrence prevention.