Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.
Department of Psychiatry, Government Medical College, Nagpur, Maharashtra, India.
Indian J Pharmacol. 2020 Mar-Apr;52(2):79-85. doi: 10.4103/ijp.IJP_441_18. Epub 2020 Jun 3.
To evaluate and compare efficacy and tolerability of Vilazodone with Escitalopram and Amitriptyline in patients of major depressive disorder(MDD).
This was a randomized, prospective, parallel-group, open label clinical study in which newly diagnosed patients of MDD were randomized to receive Tab Vilazodone 20 mg daily or Tab Escitalopram 20mg daily or Tab Amitriptyline 75mg daily for 12 weeks. Antidepressant activity was assessed by change in score from baseline to week 12 on HAMD-17 and MADRS scales while change in score on HAM-A scale was used to assess antianxiety effect. Change in scores on the three scales was also compared between the three treatment groups. Severity and causality of adverse events were assessed by the modified Hartwig & Siegel scale and Naranjo scale respectively. Data was analyzed in accordance with per protocol analysis.
Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant. Number of remitters were also significantly more in the vilazodone group (=11) compared to escitalopram (=4) (<0.05) and amitriptyline (=0) (<0.001) at 12 weeks. Similar results were also obtained with HAM-A score. Number of patients showing MADRS sustained response at 12 weeks was statistically significantly more in vilazodone (=12) and escitalopram (=12) groups compared to amitriptyline (=01) (<0.001). Reported adverse events were constipation and sedation(amitriptyline group); nausea and headache(escitalopram and vilazodone groups). These adverse events were of mild severity. Most adverse events belonged to probable category.
Vilazodone is more efficacious and well tolerated antidepressant compared to escitalopram and amitriptyline.
评估和比较维拉唑酮、艾司西酞普兰和阿米替林治疗重度抑郁症（MDD）患者的疗效和耐受性。
这是一项随机、前瞻性、平行组、开放性临床试验，新诊断的 MDD 患者被随机分为每日服用维拉唑酮 20mg 组、艾司西酞普兰 20mg 组或阿米替林 75mg 组，疗程 12 周。采用汉密尔顿抑郁量表 17 项（HAMD-17）和蒙哥马利-艾斯伯格抑郁评定量表（MADRS）评分变化评估抗抑郁疗效，汉密尔顿焦虑量表（HAMA）评分变化评估抗焦虑作用。比较三组治疗的 HAMD-17、MADRS 和 HAMA 评分变化。采用改良 Hartwig 和 Siegel 量表和 Naranjo 量表分别评估不良事件的严重程度和因果关系。根据方案分析进行数据统计。
与其他两种药物相比，维拉唑酮组 HAMD-17 和 MADRS 评分的降低更为显著，表明维拉唑酮是一种更有效的抗抑郁药。在 12 周时，维拉唑酮组的缓解人数（=11）也明显多于艾司西酞普兰组（=4）（<0.05）和阿米替林组（=0）（<0.001）。HAMA 评分也得到了类似的结果。在 12 周时，维拉唑酮组（=12）和艾司西酞普兰组（=12）的 MADRS 持续反应患者比例明显多于阿米替林组（=0）（<0.001）。报告的不良事件为便秘和镇静（阿米替林组）；恶心和头痛（艾司西酞普兰和维拉唑酮组）。这些不良事件的严重程度为轻度。大多数不良事件属于可能类别。
与艾司西酞普兰和阿米替林相比，维拉唑酮是一种更有效且耐受性更好的抗抑郁药。
