Are Cognitive Therapy's Antidepressant Effects Durable?

描述（由申请人提供）：我们建议在一项受资助的随机临床试验中增加2年随访，该试验旨在评估复发风险较高的复发性重度抑郁症（MDD）门诊患者接受持续8个月的认知治疗（C-CT）、药物治疗（氟西汀; FLX）和安慰剂（PBO）的疗效和适应症。该初始项目期将允许在所有方案治疗停止后的第一年随访后对效应的相对持久性进行评论。此外，我们将开始积累数据，以评估两年随访的效果持久性。试验和随访将由德克萨斯大学西南医学中心和匹兹堡大学医学院的研究人员进行。“高风险”定义为在急性期CT的最后几周期间的不完全缓解，而“低风险”定义为完全和稳定的缓解（即，连续7次汉密尔顿抑郁量表评分<7分）。这项试验具有重大的公共卫生意义，因为它将有助于确定CT何时降低复发性MDD患者的复发和复发风险，这种疾病具有高发病率和死亡率。复发风险最高的患者可以成为最有力的预防性治疗的目标。这项研究也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）。这种对比很重要，因为许多患者没有足够的保险来支持急性CT加延续期CT的整个过程。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。随访是重要的，因为它不仅可以评论C-CT对复发的预防作用（当患者接受它时），而且可以评论复发（停止后）。在本申请中，我们建议额外入组159例年龄在18-70岁的DSM-IV单极、非精神病性、复发性MDD的男性和女性门诊患者，进行16或20次急性期CT检查，以便有足够的把握度比较第一年随访的效果。复发风险较高的其他缓解者将随机接受8个月的：（a）C-CT、（B）FLX或（c）PBO，然后随访2年;风险较低的患者将在急性期CT后随访32个月。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。

DESCRIPTION (provided by applicant): We propose adding a 2 year follow-up to a funded, randomized clinical trial evaluating the efficacy of and indications for 8 months of continuation phase cognitive therapy (C-CT), pharmacotherapy (fluoxetine; FLX), and pill placebo (PBO) in outpatients with recurrent major depressive disorder (MDD) who are at higher risk for relapse. This initial project period will allow comment in the comparative durability of effects after the first year of follow-up after all protocol treatment is discontinued. In addition, we will begin to accrue data to evaluate the durability of effects over two years of follow-up. The trial and follow-up will be conducted by investigators 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 complete and stable remission (i.e., 7 consecutive Hamilton Rating Scale for Depression scores <7). This trial has great public health significance because it will help identify when CT reduces the risk of relapse and recurrence in patients suffering from recurrent MDD, an illness with high morbidity and mortality. Patients with the highest risk for relapse can then be targeted for the most vigorous preventive treatment. This study is also the first to evaluate the continuation phase pharmacotherapy (FLX) after incomplete remission with acute phase CT. This contrast is important because many patients do not have adequate insurance coverage to support the full course of acute CT plus continuation phase CT. Further, the pharmacotherapy group will permit tests of mode-specific vs. nonspecific therapeutic activity. The follow-up is important because it will allow comment not only on C-CT's preventive effect on relapse (while patients receive it) but also on recurrence (after it is discontinued). In this application, we propose to enter an additional 159 male and female outpatients, aged 18-70 with DSM-IV unipolar, nonpsychotic, recurrent MDD to 16 or 20 sessions of acute phase CT in order to have sufficient power to compare effects over the first year of follow-up. Additional responders at higher risk for relapse will be randomized to 8 months of: (a) C-CT, (b) FLX, or (c) PBO and then followed for 2 years; lower risk patients will be followed for 32 months after acute phase CT. Dependent variables measure response, relapse, recurrence, remission, and recovery. Blind evaluations and survival analysis are planned.