PROPHYLACTIC COGNITIVE THERAPY FOR DEPRESSION

这是一项盲法、对照、随机临床试验，旨在评估持续阶段认知治疗（C-CT）、药物治疗（氟西汀; FLX）和安慰剂（PBO）治疗复发性重度抑郁症（MDD）门诊患者的疗效和适应症，这些患者复发风险较高。 这项研究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联合进行。“较高风险”定义为在急性期CT的最后六周期间的不完全缓解，而“较低”风险定义为完全且稳定的缓解（即，连续七次汉密尔顿抑郁评定量表评分低于七分）。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作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不完全缓解后继续阶段药物治疗（FLX）的研究。 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期加延续期CT的全过程。 此外，药物治疗组将允许测试Triode特异性与非特异性治疗活性。大约340名年龄在18 - 70岁、患有DSM-IV单极、非精神病性、复发性MDD的男性和女性门诊患者将进入16次急性期CT。 约114名复发风险较高的缓解者将随机接受8个月的（a）C-CT、（B）FLX或（c）PBO治疗。 低风险患者（n = 56）将在急性期CT后随访8个月。 因变量测量响应、复发、再发、缓解和恢复。 在急性期结束时和急性期CT后4个月和8个月以及疑似复发或退出时进行盲法评估。 计划进行生存分析。

This is a blinded, controlled, randomized clinical trial to evaluate the efficacy of and indications for eight 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. The study will be conducted jointly 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 six weeks of acute phase CT, while "lower" risk is defined as a complete and stable remission (i.e., seven consecutive Hamilton Rating Scale for Depression scores of less than seven). This trial has great public health significance because it will help identify when CT reduces the risk of relapse for patients suffering from recurrent MDD, an illness with high morbidity and mortality. Patients with the highest risk for relapse can be targeted for the most vigorous preventative treatment. This study is also the first to evaluate 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 plus continuation phase CT. Further, the pharmacotherapy group will permit tests of Triode-specific versus nonspecific therapeutic activity. Approximately 340 male and female outpatients, age 18 - 70, with DSM-IV unipolar, nonpsychotic, recurrent MDD will enter 16 sessions of acute phase CT. Approximately 114 responders at higher risk for relapse will be randomized to eight months of (a) C-CT, (b) FLX, or (c) PBO. The lower risk patients (n = 56) will be followed for eight months after acute phase CT. Dependent variables measure response, relapse, recurrence, remission, and recovery. Blind evaluations occur at the end of the acute phase and at four and eight months post-acute phase CT, as well as at suspected relapse or exit. Survival analyses are planned.