A double-blind, placebo-controlled study of antidepressant augmentation with mirtazapine
A double-blind, placebo-controlled study of antidepressant augmentation with mirtazapine
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DOI：
10.1016/s0006-3223(01)01262-8
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发表时间：
2002-01-15
影响因子：
10.6
通讯作者：
Price, LH
中科院分区：
文献类型：
--
作者：
Carpenter, LL;Yasmin, S;Price, LH
背景：作者之前对 20 名抑郁症患者进行了一项开放标签米氮平增强试验，第 4 周时的缓解率为 55%。进行了一项双盲对照试验，以进一步阐明该干预措施的功效。方法：26 名尽管接受足够的抗抑郁单药治疗但仍患有持续性重度抑郁症的成人门诊患者被随机分配接受 4 周的米氮平或安慰剂增强治疗。米氮平开始时睡前服用 15 mg，第 1 周后，根据医生的判断，可能在睡前滴定至 30 mg。结果：终点时活性药物的分类阳性反应率为 64%，安慰剂为 20%。活性药物组和安慰剂组的缓解率分别为 45.4% 和 13.3%，米氮平在大多数主要结果指标上均表现出优于安慰剂的统计学显着优势，并且与整体功能和生活质量的改善相关。在出现的副作用、体重变化或主要抗抑郁药的血清浓度方面，没有显着的组间差异。结论：米氮平对于短期抗抑郁增强治疗似乎是安全有效的。生物精神病学 2002；51：183-188 (C) 2002 生物精神病学协会。
Background: A previous pilot study of open-label mirtazapine augmentation conducted by the authors in 20 depressed patients yielded a 55% response rate at week 4. A double-blind controlled trial was undertaken to further elucidate the efficacy of this intervention.Methods: 26 adult outpatients with persistent major depression despite adequate antidepressant monotherapy were randomized to receive 4 weeks of mirtazapine or placebo augmentation. Mirtazapine was begun at 15 mg at bedtime, with possible titration to 30 mg at bedtime per physician's discretion after week 1.Results: Categorical positive response rate at end point was 64% for active drug and 20% for placebo. Remission rates were 45.4% and 13.3% for active drug and placebo groups, respectively, Mirtazapine demonstrated statistically significant superiority to placebo on most major outcome measures, and was associated with improvement in overall functioning and quality of life. There were no significant group differences with regard to emergent side effects, weight change, or serum concentrations of primary antidepressants.Conclusions: Mirtazapine appears safe and effective for short-term antidepressant augmentation. Biol Psychiatry 2002;51:183-188 (C) 2002 Society of Biological Psychiatry.