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8个月的认知疗法(C-CT)、药物疗法(氟西汀；Flx)和安慰剂(PBO)对复发风险较高的严重抑郁障碍(MDD)门诊患者的疗效和适应症。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。“高风险”被定义为在急性期CT的最后六周内不完全缓解，而“低”风险被定义为完全和稳定的缓解(即，连续七个汉密尔顿评定量表，抑郁评分小于七)。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。MDD是一种发病率和死亡率都很高的疾病。可以针对复发风险最高的患者进行最有力的预防性治疗。这项研究也是第一次通过急性期CT评估不完全缓解后的继续期药物治疗(FLX)。这种对比很重要，因为许多患者没有足够的保险来支持整个急性期和延续期的CT检查。此外，药物治疗小组将允许对三极管的特异性和非特异性治疗活性进行测试。约340名年龄在18-70岁、患有DSM-IV单相、非精神病、复发MDD的男性和女性门诊患者将进入16次急性期CT检查。大约114名复发风险较高的应答者将被随机分为(A)C-CT、(B)Flx或(C)PBO治疗8个月。低危患者(n=56)急性期CT扫描后随访8个月。因变量衡量反应、复发、复发、缓解和恢复。在急性期结束时、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。生存分析已经计划好了。

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.