Santi N Simple, Biswal Sashi B, Naik Birendra Narayan, Sahoo Jyoti Prakash, Rath Bhabagrahi
Pharmacology, Veer Surendra Sai Institute of Medical Sciences and Research (VIMSAR), Burla, IND.
Psychiatry, Veer Surendra Sai Institute of Medical Sciences and Research (VIMSAR), Burla, IND.
Cureus. 2024 Jun 15;16(6):e62418. doi: 10.7759/cureus.62418. eCollection 2024 Jun.
Background and objectives The quality of life declines with the growing severity of major depressive disorder (MDD). In depressed people, medication adherence and the quality of life are mutually corrosive. These concerns spurred the investigation of relationships between treatment outcomes and adherence levels. Limited studies are looking at how vortioxetine, escitalopram, and vilazodone affect these parameters. We aimed to detect how the Short Form-36 (SF-36) had changed 16 weeks after the baseline. The connection between treatment results (as expressed by the Hamilton Depression Rating Scale or HDRS) and medication adherence (as reflected by the Morisky Medication Adherence Scale-8 or MMAS-8) was also explored. Methods An open-label, randomized, three-arm trial with 96 MDD patients was conducted. For 16 weeks, the participants were put into three groups per a 1:1:1 ratio and administered tablets of vilazodone (20-40 mg/day), escitalopram (10-20 mg/day), or vortioxetine (5-20 mg/day). There were two test drugs: vilazodone and vortioxetine; the control was escitalopram. Four weeks apart, follow-up appointments were set after the baseline visit. The HDRS, mental and physical components of SF-36, and MMAS-8 scores were evaluated in the per-protocol (PP) population. Reduced HDRS scores were indicative of improved depression symptoms. Higher MMAS-8 and SF-36 scores indicated high drug adherence and enhanced quality of life. Our analysis used the Kruskal-Wallis test, the Bonferroni correction, and the Sankey diagram. In the Clinical Trial Registry-India (CTRI), we recorded this study prospectively (2022/07/043808). Results One hundred nine (81.34%) of the 134 individuals we examined were eligible. The PP population consisted of 96 (88.07%) of them who wrapped up the 16-week study. The mean age of the group was 46.3 ± 6.2 years. For each of the three groups, the SF-36 physical component scores revealed a median difference of 24.5 (23.8-26.0), 24.0 (22.8-25.3), and 27.0 (25.0-29.0) (p = 0.001). Accordingly, the mental components of their SF-36 scores showed a median difference of 32.0 (31.0-33.3), 31.0 (29.8-34.3), and 36.0 (33.0-38.0) (p = 0.001). A median difference of -15.0 (-16.0 to -14.0), -16.0 (-17.0 to -15.0), and -16.0 (-17.0 to -15.8) was observed in the HDRS scores after 16 weeks, with respect to the baseline (p < 0.001). The median MMAS-8 scores at 16 weeks were 6.0 (6.0-7.0), 6.8 (6.0-7.0), and 7.5 (6.5-8.0) (p = 0.031). The Sankey diagram illustrated the connection between better treatment results, increased medication compliance, and decreased symptoms of depression. Conclusion In comparison to vilazodone and escitalopram, vortioxetine demonstrated a statistically significant decrease in HDRS scores and an improvement in the physical and mental component scores of the SF-36. Clinical improvements were evident in the individuals' drug adherence levels. Larger-scale studies are advised to investigate the effects of these medications on the quality of life, medication adherence, and treatment outcomes.
背景与目的 随着重度抑郁症(MDD)病情的加重,生活质量会下降。在抑郁症患者中,药物依从性和生活质量相互影响。这些问题促使人们对治疗效果与依从性水平之间的关系进行研究。目前关于伏硫西汀、艾司西酞普兰和维拉佐酮如何影响这些参数的研究有限。我们旨在检测在基线水平16周后简短健康调查问卷(SF - 36)的变化情况。同时还探讨了治疗结果(用汉密尔顿抑郁评定量表或HDRS表示)与药物依从性(用Morisky药物依从性量表 - 8或MMAS - 8反映)之间的联系。
方法 对96例MDD患者进行了一项开放标签、随机、三臂试验。参与者按1:1:1的比例分为三组,连续16周服用维拉佐酮(20 - 40毫克/天)、艾司西酞普兰(10 - 20毫克/天)或伏硫西汀(5 - 20毫克/天)片剂。有两种试验药物:维拉佐酮和伏硫西汀;对照药物为艾司西酞普兰。在基线访视后每隔四周安排一次随访预约。在符合方案(PP)人群中评估HDRS、SF - 36的心理和生理成分以及MMAS - 8评分。HDRS评分降低表明抑郁症状改善。MMAS - 8和SF - 36评分越高表明药物依从性越高且生活质量越好。我们的分析采用了Kruskal - Wallis检验、Bonferroni校正和桑基图。在印度临床试验注册中心(CTRI),我们前瞻性地记录了这项研究(2022/07/043808)。
结果 在我们检查的134名个体中,109名(81.34%)符合条件。PP人群由其中96名(88.07%)完成16周研究的个体组成。该组的平均年龄为46.3±6.2岁。三组中,SF - 36生理成分评分的中位数差异分别为24.5(23.8 - 26.0)、24.0(22.8 - 25.3)和27.0(25.0 - 29.0)(p = 0.001)。相应地,他们的SF - 36评分的心理成分中位数差异分别为32.0(31.0 - 33.3)、31.0(29.8 - 34.3)和36.0(33.0 - 38.0)(p = 0.001)。与基线相比,16周后HDRS评分的中位数差异分别为 - 15.0( - 16.0至 - 14.0)、 - 16.0( - 17.0至 - 15.0)和 - 16.0( - 17.0至 - 15.8)(p < 0.001)。16周时MMAS - 8评分的中位数分别为6.0(6.0 - 7.0)、6.8(6.0 - 7.0)和7.5(6.5 - 8.0)(p = 0.031)。桑基图展示了更好的治疗效果、更高的药物依从性和更低的抑郁症状之间的联系。
结论 与维拉佐酮和艾司西酞普兰相比,伏硫西汀在HDRS评分上有统计学显著降低,且SF - 36的生理和心理成分评分有所改善。个体的药物依从性水平有明显的临床改善。建议进行更大规模的研究来调查这些药物对生活质量、药物依从性和治疗结果的影响。