Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design
Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design
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DOI：
10.1016/s0197-2456(03)00112-0
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发表时间：
2004-02-01
期刊：
影响因子：
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通讯作者：
Niederehe, G
中科院分区：
文献类型：
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作者：
Rush, AJ;Fava, M;Niederehe, G
STAR*D是一项针对非精神病性重度抑郁症门诊患者的多地点、前瞻性、随机、多步骤临床试验。该研究比较了西酞普兰（一种选择性血清素再摄取抑制剂，抗抑郁药）治疗效果不理想的患者的各种治疗方案。该研究招募了4000名成年人（年龄在18-75岁之间），他们来自初级和专科护理机构，在当前的重度抑郁症发作期间，他们之前没有对治疗方案的反应不足或明确的不耐受。在接受西酞普兰（1级）治疗后，没有足够症状改善的参与者有资格随机分配到2级治疗，其中包括4个切换选项（舍曲林、安非他酮、文拉法辛、认知治疗）和3个西酞普兰增强选项（安非他酮、丁螺环酮、认知治疗）。那些在2级水平接受认知治疗（切换或增强选项）但没有足够改善的患者有资格随机分配到两种2A级切换选项（文拉法辛或安非他酮）之一。2级和2A级没有充分改善的参与者有资格随机分配到两个切换选项（米氮平或去甲替林）和两个增加选项（锂或甲状腺激素）添加到主要抗抑郁药（西酞普兰，安非他酮，谢曲林或文拉法辛）（3级）。那些在3级没有足够改善的患者有资格在4级随机分配到两种切换选项之一（丙氨嘧啶或米氮平和文拉法辛联合）。主要结果是由临床医生评定的17项汉密尔顿抑郁评定量表，在每个治疗水平的开始和结束时，通过电话访谈由接受治疗任务的评估员进行管理。次要结局包括自我报告的抑郁症状、身心功能、副作用负担、客户满意度、医疗保健利用和成本。有充分症状反应的参与者可以进入12个月的自然随访阶段，进行简短的月度评估和更完整的季度评估。(C) 2004爱思唯尔公司版权所有。
STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants without sufficient improvement are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments. (C) 2004 Elsevier Inc. All rights reserved.