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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.
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BACKGROUND AND OBJECTIVES: The majority of mainstream antidepressants lack the promise of complete amelioration of symptoms. Other pitfalls include the latency period and side effects. These issues prompted investigations concerning the various roles of serotonin (5-HT) neurotransmissions in the etiology of depression. In this study, each study participant received vilazodone, vortioxetine, and escitalopram monotherapy for major depressive disorder (MDD) for 16 weeks. After that, the subject's scores on the Hamilton Depression Rating Scale (HDRS)-17 item version and the Montgomery Åsberg Depression Rating Scale (MADRS) were evaluated. In the study population, we kept track of the incidence of adverse events. METHODS: Ninety-six patients with MDD participated in this open-label, randomized, three-arm study. Participants were allotted into three groups according to a 1:1:1 ratio and given vilazodone (20-40 mg/day), vortioxetine (5-20 mg/day), or escitalopram (10-20 mg/day) for 16 weeks. Vortioxetine and vilazodone are test medications, with escitalopram serving as the control. After the baseline visit, follow-up appointments were scheduled every four weeks. Per-protocol (PP) and intent-to-treat (ITT) populations served as means for efficacy and safety evaluations, respectively. We prospectively registered this research in the Clinical Trial Registry, India (CTRI) (2022/07/043808). RESULTS: Out of the 134 patients we screened, 109 (81.34%) were eligible. Ninety-six (88.07%) of them completed the 16-week trial. In the PP population (n = 96), we analyzed efficacy. They had a mean age of 46.3 ± 6.2 years. At baseline, each group's median HDRS score was 30.0 (p = 0.964). Following 16 weeks of antidepressant therapy, these scores dropped to 15.0, 14.0, and 13.0 (p = 0.002). Baseline MADRS scores for all groups were 36.0 (p = 0.741). They had corresponding values of 20.0, 18.0, and 17.0 at 16 weeks (p < 0.001). Regarding both efficacy endpoints, the post-hoc analysis with the Bonferroni correction demonstrated statistically significant differences (p < 0.001). We performed the safety assessments within our ITT population (n = 109). Ninety-six adverse events were recorded. Nonetheless, none of them seemed serious. Still, five participants opted out because of their side effects. Vomiting and nausea were the most frequent side effects. CONCLUSION: Compared to escitalopram and vilazodone, vortioxetine demonstrated a statistically significant reduction in HDRS and MADRS scores. It also had fewer and milder side effects. We recommend conducting studies involving a broader population to investigate the antidepressant effects of these medications further.
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BACKGROUND AND OBJECTIVES: The symptoms of major depressive disorder (MDD) are nowadays being assessed with the Hamilton and Montgomery-Åsberg Depression Rating Scales. However, there are few studies on the comparison of these two scales. Our study aimed to determine the correlation between the Hamilton Depression Rating Scale (HDRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) scores at baseline through 12 weeks. METHODS: An ongoing randomized, open-label, three-arm study's interim analysis is portrayed here. The participants were assessed with HDRS and MADRS at baseline, four, eight, and 12 weeks after receiving oral tablets of either vilazodone (20-40 mg/d), escitalopram (10-20 mg/d), or vortioxetine (5-20 mg/d). This study is prospectively registered with the Clinical Trial Registry, India (CTRI/2022/07/043808). RESULTS: Of 71 recruited individuals, 49 (69%) completed the 12-week visit. At baseline, the three groups' median HDRS scores were 30.0, 29.5, and 29.0 (p=0.76), and at 12 weeks, they reduced to 19.5, 19.5, and 18.0 (p=0.18). At baseline, the group-wise median MADRS scores were 36, 36, and 36 (p=0.79); at 12 weeks, they were 24, 24, and 23 (p=0.03). The Pearson correlation revealed that the association between the changes in scores from baseline was strongest for escitalopram (r=0.70, p=0.002) followed by vortioxetine (r=0.59, p=0.01) and vilazodone (r=0.59, p=0.02). The Bland-Altman analysis showed that the mean difference between the scores was 5.11 (95% CI: 3.08-7.14). CONCLUSION: According to this interim study, HDRS and MADRS scores declined after 12 weeks of therapy. Both scores had strong positive correlation, and the difference between the scores reduced with time.
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BACKGROUND AND OBJECTIVES: Individuals with major depressive disorder exhibit a dysregulated metabolic profile. There are few studies on how vilazodone, escitalopram, and vortioxetine alter metabolic parameters. Our study aimed to determine the change in plasma glucose, HbA1c, serum cholesterol, triglyceride, and creatinine at 12 weeks. METHODS: An ongoing randomized, open-label, three-arm study's interim analysis is portrayed here. The participants were assessed at baseline, 4, 8, and 12 weeks after receiving oral tablets of either vilazodone (20-40mg/d), escitalopram (10-20mg/d), or vortioxetine (5-20mg/d). This study is CTRI-registered (2022/07/043808). RESULTS: Of 71 recruited participants, 49 (69%) completed the 12-week visit. The median Hamilton Depression Rating Scale (HDRS) scores of the participants in vilazodone, escitalopram, and vortioxetine groups were 30.0, 29.5, and 29.0 at baseline (p=0.76) and 19.5, 19.5, and 18.0 (p=0.18) at 12 weeks, respectively. The median fasting blood sugar (FBS) values were 98.5, 105.5, and 98.0 at baseline (p=0.07) and 94.0, 99.5, and 96.0 (p=0.19) at 12 weeks, for vilazodone, escitalopram, and vortioxetine groups, respectively. The post hoc analysis did not yield statistically significant differences regarding any parameters. CONCLUSION: According to this interim study, the HDRS scores declined after 12 weeks of therapy. The subjects' metabolic parameters did not significantly change. It is essential to perform further investigation regarding these impacts.
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BACKGROUND AND OBJECTIVES: Quality of life and medication adherence worsen in untreated depressed individuals. Studies examining how vilazodone, escitalopram, and vortioxetine affect these factors are few and far between. Our study's objectives were to determine the change in SF-36 at 12 weeks and the association between treatment outcome and medication adherence. METHODS: This is an interim analysis of a randomized, open-label, three-arm ongoing study. The participants were evaluated at baseline, four, eight, and 12 weeks after being randomly assigned to take either vilazodone (20-40 mg/d), escitalopram (10-20 mg/d), or vortioxetine (5-20 mg/d). This study is registered with CTRI, 2022/07/043808. RESULTS: Of 71 recruited participants, 49 (69%) completed the 12-week visit. The median scores of physical components of SF-36 for the three groups were 35.5, 35.0, and 35.0 at baseline (p=0.76) and 51.0, 49.5, and 53.0 (p<0.001) at 12 weeks respectively. Their corresponding median SF-36 scores for mental components were 43.0, 43.0, and 44.0 at baseline (p=0.34) and 66.0, 63.5, and 70.0 (p<0.001) at 12 weeks. The post hoc analysis yielded a significant difference (p<0.001) regarding SF-36 scores. MMAS-8 scores among the participants were similar (p=0.22) at 12 weeks. Higher medication adherence was associated with lesser depressive symptoms (r= -0.46, p=0.001). CONCLUSION: As per this interim analysis, vortioxetine substantially impacted the SF-36 scores, juxtaposed with vilazodone and escitalopram. The participants' clinical improvements were reflected by their adherence levels. These effects need to be probed further.