COGNITIVE THERAPY FOR HIGH RISK & REFRACTORY DEPRESSION

这项独立科学家奖(KO2)的申请促进了 应聘者在人格障碍和治疗方面的研究能力 三项随机临床试验(RCT)的研究进展 关于认知疗法(CT)在降低心力衰竭的可能性方面的疗效 高危或难治性门诊患者的情绪障碍。项目1(一个 正在进行的R01)将持续阶段CT(C-CT)与仅评估进行比较 (控制)在前八个月降低复发风险 门诊复发性大出血患者急性期CT反应的观察 抑郁障碍(MDD)。约156名男性和女性门诊患者， 年龄18-65岁，共接受20次急性期CT检查。大约84 应答者被随机分为以下两组：(A)10次C-CT治疗，或 (B)仅进行10次评价(对照会议)；对受试者进行跟踪 另外16个月不含CT。评估复发/复发(如果是MDD，则为DSM) 由盲人评估者使用急性发作后4、8、12和24个月的寿命进行评估 CT期和疑似复发/复发，或退出。项目2是一个 计划与匹兹堡大学(西部)开展多站点合作 精神病学研究所和诊所(WPIC)。这种盲目的、受控的RCT将 评价8个月C-CT的疗效和适应证， 药物治疗(护理标准)(氟西汀)和安慰剂 (PBO：对照)门诊复发MDD患者 复发/复发的风险。“较高的风险”是汉密尔顿的6分。 抑郁症评定量表(HRS-D)在过去六周内的急性发作 CT期，而“低风险”被定义为6分或更低。这个 基本假设是接受C-CT或 与接受FLOX治疗的高危患者相比，FLOX患者复发前的时间更长 急性期CT+PBO。风险较低的患者将接受跟踪治疗 24个月没有做CT，预计复发/复发率为20% 急性期CT扫描后前8个月的发生率。 项目3建议与WPIC进行多站点协作，比较 (A)氟尿嘧啶和(B)氟尿嘧啶加CT在体外的疗效差异。 20个疗程急性治疗无效的复发MDD患者 CT相图。对结果的盲目评估将有助于检验预测 联合疗法对难治性抑郁症更有效 而不是只有Flx一家。 KO2将候选人的重点放在(A)识别残留症状和 CT后残留的社会损害和(B)设计治疗序列 以恢复全部功能。这些RCT有很好的公共卫生 意义重大，因为它们将帮助确定(A)CT何时降低风险 复发MDD患者的复发-复发，以及 发病率和死亡率高的疾病，以及(B)如果难治性MDD 最好用综合疗法治疗。

This request for an Independent Scientist Award (KO2) fosters the candidate's research proficiency in personality disorders and treatment development within the context of three randomized clinical trials (RCTs) on the efficacy of cognitive therapy (CT) in reducing the likelihood of mood disorders in high risk or refractory outpatients. Project 1 (an ongoing R01) compares continuation phase CT (C-CT) to evaluation only (control) in reducing the risk of relapse during the first eight months following response to acute phase CT in outpatients with recurrent major depressive disorder (MDD). Approximately 156 male and female outpatients, aged 18-65, have entered 20 sessions of acute phase CT. Approximately 84 responders were randomized to either 8 months of: (a) 10 C-CT sessions, or (b) 10 evaluation only (control sessions); subjects are followed for an additional 16 months CT free. Relapse/recurrence (DSM IF MDD) is assessed by a blind evaluator using the LIFE at 4, 8, 12, and 24 months post-acute phase CT and at suspected relapse/recurrence, or exit. Project 2 is a proposed, multi-site collaboration with University of Pittsburgh (Western Psychiatric Institute and Clinic; WPIC). This blinded, controlled RCT will evaluate the efficacy of and indications for eight months of C-CT, pharmacotherapy (the standard of care) (FLX: fluoxetine), and pill placebo (PBO: the control) in outpatients with recurrent MDD who are at higher risk for relapse/recurrence. "Higher risk" is a score >6 on the Hamilton Rating Scale for Depression (HRS-D) during the last six weeks of acute phase CT, while "lower risk" is defined as a score of 6 or less. The primary hypotheses is that higher risk patients who receive either C-CT or FLX have a longer time until relapse than higher risk patients who receive acute phase CT only plus PBO. The lower risk patients will be followed for 24 months without CT and are predicted to have a 20% relapse/recurrence rate in the first 8 months after acute phase CT. Project 3 is a proposed, multi-site collaboration with WPIC comparing the differential efficacy of a trial of: (a) FLX and (b) FLX plus CT in out- patients with recurrent MDD who were refractory to 20 sessions of acute phase CT. Blind evaluation of outcome will aid in testing the prediction that combination therapy is more efficacious for refractory depression than FLX alone. The KO2 focuses the candidate on (a) identifying the residual symptoms and social impairment remaining after CT and (b) designing treatment sequences to restore full functioning. These RCTs have great public health significance because they will help identify (a) when CT reduces the risk of relapse-recurrence for patients suffering from recurrent MDD, an illness with high morbidity and mortality, and (b) if refractory MDD is best treated with combination therapy.