A Randomized Controlled Trial of Sertraline for the Treatment of Depression in Persons With Traumatic Brain Injury
A Randomized Controlled Trial of Sertraline for the Treatment of Depression in Persons With Traumatic Brain Injury
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DOI：
10.1016/j.apmr.2008.11.005
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发表时间：
2009-05-01
影响因子：
4.3
通讯作者：
Greenwald, Brian
中科院分区：
文献类型：
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作者：
Ashman, Teresa A.;Cantor, Joshua B.;Greenwald, Brian
目的：研究舍曲林治疗创伤性脑损伤（TBI）后抑郁症的疗效。设计：双盲、随机对照试验。设置：一个主要城市医疗中心的研究中心。参与者：受试者是52名TBI参与者的转诊和志愿者样本，TBI是一种诊断为重度抑郁症（MDD）的疾病，并且抑郁症的汉密尔顿评定量表（HAM-D）得分为18或更高。样本中的大多数是男性（58%），受教育时间不到14年（73%），收入低于20，000美元（82%），来自少数民族背景（75%）。大约三分之一的样本有轻度脑损伤，三分之二有中度至重度脑损伤。平均年龄为47 +/- 11岁，平均受伤时间为17 +/- 14年。一名参与者因副作用而退出研究。干预措施：每日口服舍曲林，剂量从25毫克开始，逐渐增加到治疗水平主要结果测量：HAM-D、比克焦虑量表和Life-3生活质量（QOL）。结果：基线时，药物组和安慰剂组之间的抑郁基线测量值无统计学显著差异（24.8 ± 7.3 vs 27.7 ± 7.0）、焦虑（16.4 ± 12.3 vs 24.0 ± 14.9）或QOL（2.96 ± 1.0 vs 2.9 ± 0.9）。接受安慰剂的人的收入水平明显低于接受药物治疗的人。协方差分析显示，从干预前到治疗后，所有3项结局指标均发生了显著变化（P
Objective: To examine the efficacy of sertraline in the treatment of depression after traumatic brain injury (TBI).Design: Double-blind, randomized controlled trial.Setting: Research center at a major urban medical center.Participants: Subjects were a referred and volunteer sample of 52 participants with TBI, a diagnosis of major depression disorder (MDD), and a score on the Hamilton Rating Scale for Depression (HAM-D) of 18 or greater. The majority of the sample was male (58%), had less than 14 years of education (73%), had incomes below $20,000 (82%), and were from minority backgrounds (75%). Approximately one third of the sample had mild brain injuries, and two thirds had moderate to severe brain injuries. The mean age was 47 +/- 11, and the mean time since injury was 17 +/- 14 years. One participant withdrew from the study because of side effects.Intervention: Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) or placebo for 10 weeks.Main Outcome Measures: The HAM-D, the Beek Anxiety Inventory, and the Life-3 quality of life (QOL).Results: No statistically significant differences were found at baseline between drug and placebo groups on baseline measures of depression (24.8 +/- 7.3 vs 27.7 +/- 7.0), anxiety (16.4 +/- 12.3 vs 24.0 +/- 14.9), or QOL (2.96 +/- 1.0 vs 2.9 +/- 0.9). The income level of those receiving placebo was significantly lower than those participants receiving medication. Analyses of covariance revealed significant changes from preintervention to posttreatment for all 3 Outcome measures (P