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首页> 外文期刊>The journal of clinical psychiatry >A double-blind, randomized, placebo-controlled clinical trial of S-Adenosyl-L-Methionine (SAMe) versus escitalopram in major depressive disorder
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A double-blind, randomized, placebo-controlled clinical trial of S-Adenosyl-L-Methionine (SAMe) versus escitalopram in major depressive disorder

机译：S-腺苷-L-蛋氨酸（SAMe）与依他普仑治疗重大抑郁症的双盲，随机，安慰剂对照临床试验

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Objective: To examine the comparative antidepressant efficacy of 5-adenosyl- -methionine (SAMe) and escitalopram in a placebo-controlled, randomized, double-blind clinical trial. Method: One hundred eighty-nine outpatients (49.7% female, mean [SD] age 45 [15] years) with D5M-IV diagnosed major depressive disorder (MDD) were recruited from April 13, 2005, to December 22, 2009, at the Massachusetts General Hospital and at Butler Hospital. Patients were randomized for 12 weeks to SAMe 1,600 3,200 mg/d, escitalopram 10 20 mg/d, or placebo. Doses were escalated at 6 weeks in the event of nonresponse.The main outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS-1 7). Tolerability was assessed by the Systematic Assessment forTreatment of Emergent Events-Specific Inquiry (SAFTEE-SI). Results: All 3 treatment arms demonstrated a significant improvement ofabout 5 6 points in HDRS-1 7 scores (P< .001 for all), and no significant differences were observed between the treatment arms (P>.05 for all). Response rates in the intent-to- treat sample were 36% for SAMe, 34% for escitalopram, and 30% for placebo. Remission rates were 28% for SAMe, 28% for escitalopram, and 17% for placebo. No comparisons between treatment groups attained significance (P> .05 for all). Tolerability was good, with gastrointestinal side effects (19% for stomach discomfort and 20% for diarrhea) as the most common in the SAMe arm. Significant differences were observed between treatment groups for dizziness, anorgasmia, diminished mental acuity, and hot flashes (P< .05 for all). Conclusions: The results fail to support an advantage over placebo for either the investigational treatment SAMe or the standard treatment escitalopram for MDD. Trial Registration: Clinica ITria ls.gov identifier: NCTOO1 01452.
机译：目的：在安慰剂对照，随机，双盲临床试验中，研究5-腺苷-甲硫氨酸（SAMe）和艾司西酞普兰的抗抑郁作用的比较。方法：从2005年4月13日至2009年12月22日，招募了189名D5M-IV诊断为重度抑郁症（MDD）的门诊患者（女性为49.7％，平均[SD]年龄为45 [15]岁）。马萨诸塞州总医院和巴特勒医院。患者随机分为12周服用SAMe 1,600 3,200 mg / d，依他普仑10 20 mg / d或安慰剂。如果没有反应，则在6周时增加剂量。主要结果指标是17个项目的汉密尔顿抑郁量表（HDRS-1 7）。耐受性通过紧急事件特定查询系统评估（SAFTEE-SI）进行评估。结果：所有3个治疗组的HDRS-1 7得分均显着改善了约5 6个点（所有P均<0.001），治疗组之间未观察到显着差异（所有P均> 0.05）。意向性治疗样本中的SAMe应答率为36％，依西酞普兰为34％，安慰剂为30％。 SAMe的缓解率为28％，依他普仑的缓解率为28％，安慰剂的缓解率为17％。治疗组之间没有比较达到显着性（所有P> 0.05）。耐受性良好，在SAMe组中最常见的是胃肠道副作用（胃部不适为19％，腹泻为20％）。在治疗组之间观察到头晕，厌食，精神敏锐度降低和潮热的显着差异（所有P均<0.05）。结论：该结果不能支持相比于安慰剂，无论是用于研究治疗的SAMe还是用于MDD的标准治疗依他普仑。试用注册：Clinica ITria ls.gov标识符：NCTOO1 01452。

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