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首页> 外文期刊>The journal of clinical psychiatry >Efficacy of mirtazapine for prevention of depressive relapse: a placebo-controlled double-blind trial of recently remitted high-risk patients.
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Efficacy of mirtazapine for prevention of depressive relapse: a placebo-controlled double-blind trial of recently remitted high-risk patients.

机译：米氮平预防抑郁症复发的功效：安慰剂对照的双盲试验，用于近期缓解的高危患者。

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BACKGROUND: The necessity of antidepressant continuation-phase therapy following acute-phase response has resulted in the need to characterize the longer-term efficacy and safety of all new medications. Previous studies using "extension" protocols suggest that mirtazapine has sustained antidepressant effects. The current study was performed to evaluate the efficacy and safety of up to 1 year of mirtazapine therapy, using a more rigorous, randomized, placebo-controlled discontinuation design. METHOD: An intent-to-treat sample of 410 patients meeting DSM-IV criteria for moderate-to-severe recurrent or chronic major depressive episodes began 8 to 12 weeks of open-label therapy with mirtazapine (flexibly titrated, 15-45 mg/day). Thereafter, 156 fully remitted patients (according to Hamilton Rating Scale for Depression and Clinical Global Impressions-Improvement scores) were randomly assigned to receive 40 weeks of double-blind continuation-phase therapy with either mirtazapine or placebo. RESULTS: Mirtazapine therapy reduced the rate of depressive relapse by more than half, with 43.8% of patients relapsing on treatment with placebo as compared with 19.7% of the mirtazapine-treated patients. The discontinuation rate due to adverse events was 11.8% for active mirtazapine therapy versus 2.5% for placebo. Although weight gain was significantly greater in the group receiving active medication during the double-blind phase (p = .001), patients taking mirtazapine gained only 1.4 kg (3.1 lb) across the 40 weeks of continuation therapy, and there was no difference in the rates of weight gain as a newonset adverse event. CONCLUSION: Continuation-phase therapy with mirtazapine is effective and well tolerated.
机译：背景：急性期反应后必须继续接受抗抑郁药治疗，因此需要表征所有新药的长期疗效和安全性。先前使用“扩展”方案的研究表明，米氮平具有持续的抗抑郁作用。本研究使用更严格，随机，安慰剂对照的停药设计进行，以评估米氮平治疗长达1年的疗效和安全性。方法：对410名符合DSM-IV标准的中至重度复发或慢性重度抑郁发作的患者进行意向性治疗，开始使用米氮平进行开放标签治疗的8至12周（灵活滴定剂量为15-45 mg /天）。此后，随机分配156名完全缓解的患者（根据汉密尔顿抑郁量表和临床总体印象-改善评分），接受米氮平或安慰剂的40周双盲持续治疗。结果：米氮平治疗使抑郁症复发率降低了一半以上，接受安慰剂治疗的患者复发率为43.8％，而米氮平治疗的患者为19.7％。积极的米氮平治疗因不良事件引起的停药率为11.8％，而安慰剂为2.5％。尽管在双盲阶段接受活性药物治疗的组体重增加明显更大（p = .001），但服用米氮平的患者在连续治疗的40周中仅增加了1.4千克（3.1磅），并且体重增加率作为新发作的不良事件。结论：米氮平持续期治疗有效且耐受性良好。

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