Prophylactic Cognitive Therapy for Depression

描述（由申请人提供）：在本次竞争性更新申请中，我们要求提供五年的模块化资金，以继续我们的目标，完成第一个充分把握度的安慰剂（PBO）对照随机临床试验，评估持续阶段认知治疗（C-CT）和氟西汀（FLX）在复发高危复发性重度抑郁症（MOD）门诊患者中的疗效。该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最后几周的不完全缓解，而“低风险”定义为完全和稳定的缓解。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确定那些复发风险最大的患者，这些患者需要更长的疗程，并可以为患者提供更多的预防复发的选择。这种基于诊断的决策规则可以通过为抑郁发作提供足够的治疗来降低护理成本，而不会对低风险患者进行“过度治疗”或对高风险患者进行“治疗不足”。这项研究是第一个评估急性期CT不完全缓解后的继续阶段药物治疗（FLX）。此外，药物治疗组将允许测试模式特异性与非特异性治疗活性。因变量测量响应、复发、再发、缓解和恢复。计划进行盲法评价和生存分析。根据IRQ要求的中期分析结果和当前复发率（即，C-CT 10% ; FLX 22%;和PBO 22%），把握度分析显示，共需要120例新随机化受试者来比较C-CT与FLX的疗效。本申请拟随机分配90例患者，并继续进行不平衡的3组试验。(In第7-11年，只有5%的患者将被随机分配至PBO组，以最大限度地提高C-CT和FLX比较的统计功效，而不会破坏原始设计或改变患者或工作人员的期望。在本次更新期间，180例所需的新患者将入组急性期认知治疗（A-CT）。在本项目期结束时，所有资金的累积总计：A-CT n=665例所需患者，随机化将等于C-CT所需患者中的107例; FLX所需患者中的107例; PBO所需患者中的53例。

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.