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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.
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INTRODUCTION: The troubling issues of conventional antidepressants are inadequate disease remission and potential adverse effects. There is a dearth of research findings comparing vilazodone, escitalopram, and vortioxetine. The objective of this analysis is to determinechanges in the Hamilton Depression Rating Scale (HDRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) scoresand the incidence of adverse events at 12 weeks. METHODS: This is an exploratory interim analysis of a randomized, three-arm, open-label ongoing study. The participants were randomly assigned in a 1:1:1 ratio to receive either vilazodone (20-40 mg/d), escitalopram (10-20 mg/d), or vortioxetine (5-20 mg/d). Efficacy and safety assessments were done at baseline, four weeks, eight weeks, and 12 weeks. RESULTS: Forty-nine(69%) of the 71 enrolled participants (mean age 43.9±12.2 years; 37 men (52%)) completed the 12-week follow-up. At baseline, the three groups' median HDRS scores were 30.0, 29.5, and 29.0 (p=0.76), respectively, and at 12 weeks, they amounted to 19.5, 19.5, and 18.0 (p=0.18), respectively. At baseline, group-wise median MADRS scores were 36, 36, and 36, respectively (p=0.79); at 12 weeks, they were 24, 24, and 23, respectively (p=0.03). In the post-hoc analysis, the inter-group comparison of the change in HDRS (p = 0.02) and MADRS (p = 0.06) scores from baseline did not reach statistical significance. No participants experienced serious adverse events. CONCLUSION: In this initial assessment of a continuing study, vortioxetine exhibited a clinically (not statistically) significant drop in HDRS and MADRS scores, compared to vilazodone and escitalopram. The antidepressant effects need to be investigated further.
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BACKGROUND: Malaria remains a major health hazard in the modern world, particularly in developing countries. In Plasmodium falciparum malaria, there is a direct correlation between asexual erythrocytic stage parasite density and disease severity. Accordingly, the correlations between parasite density and various clinical presentations, severity, and outcome were examined in falciparum malaria in India. MATERIALS AND METHODS: The study was conducted in a tertiary health-care center in North India. Of 100 cases of falciparum malaria, 65 patients were male and 35 were female. A total of 54 patients were in the uncomplicated group and 46 patients were in the complicated malaria group. RESULTS: Fever, anemia, icterus, splenomegaly, hepatomegaly, and hepatosplenomegaly were common clinical findings. All clinical findings were significantly more common in the complicated malaria group and patients with a high parasite density than in the uncomplicated group and those with a low parasite density. All patients in the uncomplicated malaria group had a parasite density of <5% while most patients in the complicated malaria group had a parasite density of >5%, and the difference between groups was statistically significant. The incidence of cerebral malaria was significantly higher in cases with a high parasite density; 58.33% mortality was observed in these cases. Cerebral malaria and hyperbilirubinemia was the most frequently encountered combination of complications. CONCLUSIONS: In P. falciparum malaria, parasite density was associated with complications and poor clinical outcomes. These results may inform treatment decisions and suggest that a threshold parasite density of 5% is informative.
