PROPHYLACTIC COGNITIVE THERAPY FOR DEPRESSION

这是一项盲法、对照、随机临床试验，旨在评估复发风险较高的复发性重度抑郁症 (MDD) 门诊患者连续八个月的认知治疗 (C-CT)、药物治疗（氟西汀；FLX）和安慰剂安慰剂 (PBO) 的疗效和适应症。 该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”的定义是急性期 CT 的最后六周内不完全缓解，而“较低”风险的定义是完全且稳定的缓解（即连续七次汉密尔顿抑郁量表评分低于七）。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 何时可以降低复发性 MDD（一种发病率和死亡率较高的疾病）患者复发的风险。 复发风险最高的患者可以接受最有力的预防性治疗。 这项研究也是第一个评估急性期 CT 不完全缓解后的持续期药物治疗 (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加持续期 CT 的整个疗程。 此外，药物治疗小组将允许测试 Triode 特异性与非特异性治疗活性。大约 340 名年龄 18 - 70 岁、患有 DSM-IV 单相、非精神病性、复发性 MDD 的男性和女性门诊患者将接受 16 次急性期 CT 治疗。 大约 114 名复发风险较高的应答者将被随机分配接受八个月的 (a) C-CT、(b) FLX 或 (c) PBO。 低风险患者 (n = 56) 将在急性期 CT 后随访八个月。 因变量衡量反应、复发、复发、缓解和恢复。 盲法评估发生在急性期结束时和急性期 CT 后四个月和八个月，以及疑似复发或退出时。 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.