天普汀 25-50 毫克治疗老年复发性重度抑郁症患者的疗效：8 周安慰剂和依地普仑对照研究。

Efficacy of Tianeptine 25-50 mg in Elderly Patients With Recurrent Major Depressive Disorder: An 8-Week Placebo- and Escitalopram-Controlled Study.

机构信息

Department of Psychiatry, Faculty of Medicine and Health Sciences, University of Stellenbosch, Clinical Bldg Fransie van Zyl Ave, Parow, Cape Town 8000 South Africa.

Department of Psychiatry, Faculty of Medicine and Health Sciences, University of Stellenbosch, Parow, Cape Town, South Africa.

出版信息

J Clin Psychiatry. 2018 Jul 3;79(4):17m11741. doi: 10.4088/JCP.17m11741.

DOI:10.4088/JCP.17m11741

PMID:29995359

Abstract

OBJECTIVE

The present placebo-controlled study evaluated the efficacy and safety of 8 weeks of treatment with tianeptine 25-50 mg/d in elderly patients suffering from major depressive disorder (MDD) according to DSM-IV-TR. Escitalopram 5-10 mg/d was used as an active comparator.

METHODS

Elderly outpatients aged at least 65 years with a primary diagnosis of moderate to severe episode of recurrent MDD were recruited by psychiatrists in 44 clinical centers in 10 countries from October 2013 to January 2016. Patients were randomly assigned to receive tianeptine (n = 105), placebo (n = 107), or escitalopram (n = 99) for 8 weeks. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS₁₇) total score.

RESULTS

Tianeptine improved depressive symptoms, as evaluated by the HDRS₁₇ total score in terms of absolute change from baseline (week 0) to week 8 (placebo-tianeptine difference [SE] of 3.84 [0.85] points, P < .001, using a last-observation-carried-forward approach) and response to treatment (tianeptine: 46.7%; placebo: 34.0%, estimate [SE] = 12.70% [6.70], P = .06). A sensitivity analysis using a mixed model for repeated measures confirmed the main results on HDRS total score. The placebo-tianeptine difference (SE) was 0.66 (0.15) for Clinical Global Impressions-Severity of Illness (95% CI, 0.37 to 0.96; P < .001) and 0.57 (0.14) for Clinical Global Impressions- Improvement (95% CI, 0.30 to 0.83; P < .001). Positive results were also obtained with the active control escitalopram (HDRS₁₇ total score placebo-escitalopram difference of 4.09 ± 0.86 points, P < .001), therefore validating the sensitivity of the studied population. Tianeptine was well tolerated, with only minimal differences in tolerability from placebo.

CONCLUSIONS

The present study provides robust evidence that an 8-week treatment period with tianeptine 25-50 mg is efficacious and well tolerated in depressed patients aged 65 years or older.

TRIAL REGISTRATION

EudraCT identifier: 2012-005612-26.

摘要

目的

本安慰剂对照研究根据 DSM-IV-TR 评估了 8 周替奈普汀 25-50mg/d 治疗老年重度抑郁障碍（MDD）患者的疗效和安全性。艾司西酞普兰 5-10mg/d 用作活性对照。

方法

2013 年 10 月至 2016 年 1 月，来自 10 个国家的 44 个临床中心的精神科医生招募了年龄至少 65 岁且原发性诊断为中重度复发性 MDD 的老年门诊患者。患者被随机分配接受替奈普汀（n=105）、安慰剂（n=107）或艾司西酞普兰（n=99）治疗 8 周。主要结局测量是 17 项汉密尔顿抑郁评定量表（HDRS₁₇）总分。

结果

替奈普汀改善了抑郁症状，根据从基线（第 0 周）到第 8 周的 HDRS₁₇ 总分的绝对变化（替奈普汀-安慰剂差值为 3.84 [0.85]，P<0.001，采用最后观察值结转方法）和治疗反应（替奈普汀：46.7%；安慰剂：34.0%，估计值[SE]=12.70%[6.70]，P=0.06）。使用重复测量混合模型进行的敏感性分析证实了 HDRS 总分的主要结果。替奈普汀-安慰剂差值（SE）为 0.66（0.15），用于临床总体印象-疾病严重程度（95%CI，0.37 至 0.96；P<0.001）和 0.57（0.14），用于临床总体印象-改善（95%CI，0.30 至 0.83；P<0.001）。阳性结果也在活性对照艾司西酞普兰中得到（HDRS₁₇ 总分替奈普汀-艾司西酞普兰差值为 4.09±0.86，P<0.001），因此验证了研究人群的敏感性。替奈普汀耐受性良好，与安慰剂相比仅有微小的耐受性差异。