COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL.
COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL.
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DOI：
10.1002/da.22384
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发表时间：
2015-08
影响因子：
7.4
通讯作者：
Wall MM
中科院分区：
文献类型：
--
作者：
Schneier FR;Campeas R;Carcamo J;Glass A;Lewis-Fernandez R;Neria Y;Sanchez-Lacay A;Vermes D;Wall MM
选择性血清素再摄取抑制剂（SSRI）与米氮平联合治疗在一些抑郁症研究中显示出优越的疗效，但尚未对创伤后应激障碍（PTSD）进行研究。本研究旨在评估舍曲林加米氮平联合治疗PTSD的可接受性，并评估其相对于舍曲林加安慰剂的效应大小。36名患有创伤后应激障碍的成年人被随机分配到24周的双盲治疗中，使用舍曲林加米氮平或舍曲林加安慰剂。结果采用混合效应模型进行分析。联合治疗组的缓解率（P = 0.042）和抑郁症状的改善（P = 0.023）明显高于舍曲林加安慰剂组。在治疗保留和创伤后应激障碍严重程度这两个主要结局，或其他次要结局（睡眠障碍、性功能、生活质量和身心功能）方面，组间没有显著差异，但联合治疗组在所有这些结局上都显示出数值优势，相对于舍曲林加安慰剂的效应大小从小到中等（d = 0.26 - 0.63）。两种治疗方法的耐受性都很好，联合治疗组的食欲明显增加，但体重没有增加。研究结果表明，与单独使用SSRI治疗相比，舍曲林加米氮平联合治疗PTSD在症状改善方面可能具有临床意义的优势，并且耐受性可接受。SSRI联合米氮平治疗创伤后应激障碍值得进一步研究，作为初始治疗或作为对SSRI无反应的增强策略。NCT01178671
Combined treatment with a selective serotonin reuptake inhibitor (SSRI) plus mirtazapine has shown superior efficacy in some studies of depression but has not been studied in posttraumatic stress disorder (PTSD). This study aimed to assess acceptability of combined sertraline plus mirtazapine treatment for PTSD and to estimate its effect size relative to sertraline plus placebo. Thirty-six adults with PTSD were randomized to 24 weeks of double-blind treatment with sertraline plus mirtazapine or sertraline plus placebo. Outcomes were analyzed with mixed effects models. The combined treatment group showed a significantly greater remission rate (P = 0.042) and improvement in depressive symptoms (P = 0.023) than the sertraline plus placebo group. There were no significant group differences in the two primary outcomes of treatment retention and PTSD severity, or in other secondary outcomes (sleep impairment, sexual functioning, quality of life, and physical and mental functioning), but the combined treatment group showed numerical advantages on all of these outcomes, and effect sizes relative to sertraline plus placebo ranged from small to moderate (d = 0.26 - 0.63). Both treatments were well-tolerated, with significantly increased appetite but not weight gain in the combined treatment group. Findings suggest that combined treatment of PTSD with sertraline plus mirtazapine may have clinically meaningful advantages in symptomatic improvement, relative to SSRI treatment alone, and acceptable tolerability. Combined treatment with an SSRI plus mirtazapine in PTSD deserves additional study as initial treatment or as an augmentation strategy for nonresponders to an SSRI. NCT01178671