Prophylactic Cognitive Therapy for Depression

描述（由申请人提供）：在此竞争性续期申请中，我们要求五年的模块化资助，以继续我们的目标，完成第一个充分动力，安慰剂（PBO）对照随机临床试验，评估持续期认知疗法（C-CT）和氟西汀（FLX）对复发性重度抑郁症（MOD）门诊患者的疗效，这些患者复发的风险很高。这项试验正在德克萨斯大学西南医学中心和匹兹堡大学医学院进行。“高风险”定义为急性期CT最后几周不完全缓解，而“低风险”定义为完全稳定缓解。这项试验具有重大的公共卫生意义，因为它将帮助临床医生识别那些复发风险最大、需要更长疗程的患者，并为患者提供更多预防复发的选择。这种基于经验的决策规则可以通过为抑郁症发作提供足够的治疗来降低护理成本，既不会“过度治疗”低风险患者，也不会“治疗不足”高风险患者。该研究首次评估急性期CT不完全缓解后的持续期药物治疗（FLX）。此外，药物治疗组将允许对模式特异性和非特异性治疗活性进行测试。因变量衡量反应、复发、复发、缓解和恢复。计划进行盲评价和生存分析。根据IRQ要求的中期分析结果和当前复发率（即C-CT为10%，FLX为22%，PBO为22%），功率分析显示，总共需要120名新随机受试者来比较C-CT和FLX的疗效。本申请建议随机选取90例患者，并继续进行不平衡的三组试验。（在7-11年级，只有5%的患者将被随机分配到PBO，以最大限度地提高C-CT和FLX比较的统计效力，同时不破坏原始设计或改变患者或工作人员的期望）。在此更新期间，180名所需的新患者将纳入急性期认知治疗（A-CT）。在本项目结束时，所有资金的累积将达到：A-CT n=665名所需患者，随机化将等于107名所需C-CT患者；FLX中要求的107；53例患者需要PBO。

DESCRIPTION (provided by applicant): In this application for competing renewal, we request five years of modular funding to continue our aim to complete the first adequately powered, placebo (PBO) controlled randomized clinical trial evaluating the efficacy of continuation phase cognitive therapy (C-CT) and fluoxetine (FLX) in outpatients with recurrent Major Depressive Disorder (MOD) who are at high risk for relapse. The trial is being conducted at The University of Texas Southwestern Medical Center and The University of Pittsburgh School of Medicine. "Higher risk" is defined by incomplete remission during the final weeks of acute phase CT, while "lower risk" is defined as a complete and stable remission. This trial has great public health significance because it will help clinicians to identify those patients at greatest risk for relapse who warrant longer courses of treatment and can produce greater choices for patients in relapse prevention. Such empirically-based decision rules could lower the cost of care by providing enough treatment for a depressive episode without either "over- treating" patients at lower risk or "under-treating" those patients at higher risk. This study is the first to evaluate continuation phase pharmacotherapy (FLX) after incomplete remission with acute phase CT. Further, the pharmacotherapy group will permit tests of mode-specific vs. non-specific therapeutic activity. Dependent variables measure response, relapse, recurrence, remission, and recovery. Blind evaluations and survival analyses are planned. Based on results of an interim analysis requested by the IRQ and on current relapse rates (i.e., C-CT 10% ; FLX 22 %; and PBO 22%), the power analysis showed that a total of 120 newly randomized subjects are needed to compare the efficacy C-CT vs. FLX. This application proposes to randomize 90 patients and continue as an unbalanced 3-arm trial. (In Year 7-11 only 5% of patients will be randomized to PBO to maximize the statistical power for comparison of C-CT and FLX, without undermining the original design or changing patient or staff expectations). During this renewal, 180 of the required new patients will be enrolled into acute phase cognitive therapy (A-CT). At the end of this project period accrual across all funding will total: A-CT n=665 of the required patients and randomization will equal 107 of the required patients in C-CT; of the required 107 in FLX; and 53 of the patients required for PBO.