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米诺环素辅助治疗抵抗性抑郁症状:一项先导随机安慰剂对照试验。

Minocycline as an adjunct for treatment-resistant depressive symptoms: A pilot randomised placebo-controlled trial.

机构信息

1 Camden and Islington NHS Foundation Trust, London, UK.

2 Pakistan Institute of Living and Learning, Karachi, Pakistan.

出版信息

J Psychopharmacol. 2017 Sep;31(9):1166-1175. doi: 10.1177/0269881117724352. Epub 2017 Aug 31.

Abstract

BACKGROUND

Evidence suggests that anti-inflammatory medication may be effective in the treatment of depressive symptoms. In this study, we aimed to investigate whether minocycline added to treatment as usual (TAU) for 3 months in patients with treatment-resistant depression will lead to an improvement in depressive symptoms.

METHODS

Multi-site, 12-week, double-blind, placebo-controlled, pilot trial of minocycline added to TAU for patients suffering from DSM-5 major depressive disorder, whose current episode has failed to respond to at least two antidepressants. The primary outcome measure was mean change in Hamilton Depression Rating Scale (HAMD-17) scores from baseline to week 12. Secondary measures were the Clinical Global Impression scale (CGI), Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder scale (GAD-7) and EuroQoL (EQ-5D) quality-of-life questionnaire. Side-effect checklists were also used. Minocycline was started at 100 mg once daily (OD) and increased to 200 mg after 2 weeks.

RESULTS

A total of 41 participants were randomised, with 21 in the minocycline group and 20 in the placebo group. A large decrease in HAMD scores was observed in the minocycline group compared to the placebo group (standardised effect size (ES) -1.21, p < 0.001). CGI scores in the minocycline group also showed a large improvement compared with placebo (odds ratio (OR): 17.6, p < 0.001). PHQ-9, GAD-7 and EQ-5D total showed more moderate improvements (ES ~ 0.4-0.5).

CONCLUSION

The findings indicate that adjunctive minocycline leads to improvement in symptoms of treatment-resistant depression. However, our findings require replication in a larger sample.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02263872, registered October 2014.

摘要

背景

有证据表明,抗炎药物可能对治疗抑郁症状有效。在这项研究中,我们旨在研究在接受治疗抵抗性抑郁症的患者中,将米诺环素添加到常规治疗(TAU)中 3 个月是否会导致抑郁症状的改善。

方法

多中心、12 周、双盲、安慰剂对照的米诺环素添加到 TAU 治疗方案的试验,用于治疗 DSM-5 重性抑郁障碍患者,这些患者目前的发作对至少两种抗抑郁药没有反应。主要的结局测量是从基线到第 12 周时汉密尔顿抑郁评定量表(HAMD-17)评分的平均变化。次要测量是临床总体印象量表(CGI)、患者健康问卷-9(PHQ-9)、广泛性焦虑障碍量表(GAD-7)和 EuroQoL(EQ-5D)生活质量问卷。还使用了副作用检查表。米诺环素从 100mg 每日 1 次(OD)开始,两周后增加到 200mg。

结果

共有 41 名参与者被随机分配,米诺环素组 21 名,安慰剂组 20 名。与安慰剂组相比,米诺环素组的 HAMD 评分有较大下降(标准化效应量(ES)-1.21,p<0.001)。米诺环素组的 CGI 评分也较安慰剂组有较大改善(比值比(OR):17.6,p<0.001)。PHQ-9、GAD-7 和 EQ-5D 总评分显示出更适度的改善(ES 约为 0.4-0.5)。

结论

研究结果表明,辅助米诺环素可改善治疗抵抗性抑郁症的症状。然而,我们的发现需要在更大的样本中得到复制。

试验注册

ClinicalTrials.gov 标识符:NCT02263872,于 2014 年 10 月注册。

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