Prophylactic Cognitive Therapy for Depression

描述(申请人提供)：在这份竞争性续签申请中，我们请求五年的模块化资金，以继续我们的目标，以完成第一个充分有效的安慰剂(PBO)对照随机临床试验，评估持续阶段认知疗法(C-CT)和氟西汀(Floxetine)对复发风险高的重度抑郁障碍(MOD)门诊患者的疗效。该试验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”被定义为在急性期CT的最后几周不完全缓解，而“低风险”被定义为完全稳定的缓解。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识别哪些患者的复发风险最高，需要更长的疗程，并可以为患者提供更多的选择来预防复发。这种基于经验的决策规则可以降低护理成本，因为它可以为抑郁发作提供足够的治疗，而不会对风险较低的患者进行过度治疗，也不会对风险较高的患者进行治疗不足。这项研究是首次通过急性期CT评估不完全缓解后继续期药物治疗(FLX)的效果。此外，药物治疗组将允许对特定模式与非特定治疗活动进行测试。因变量衡量反应、复发、复发、缓解和恢复。计划进行盲目评估和生存分析。根据IRQ要求的中期分析结果和当前复发率(即C-CT 10%；FLX 22%；PBO 22%)，POWER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。该应用程序建议将90名患者随机分组，并继续进行不平衡的三组试验。(在7-11年，只有5%的患者将被随机分配到PBO，以最大限度地发挥C-CT和FLX比较的统计能力，而不会破坏最初的设计或改变患者或工作人员的期望)。在这次更新期间，180名所需的新患者将接受急性期认知治疗(A-CT)。在本项目期结束时，所有资助的应计项目将总计：A-CT n=665名所需患者，随机分组将相当于C-CT所需患者的107名；FLX所需107名患者的107名；以及PBO所需患者的53名。

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.