Vortioxetine significantly improved fasting plasma glucose (90.8 vs 93.9 mg/dL, p=0.003) and waist circumference (81.45 vs 84.75 cm, p=0.005) compared to fluoxetine over 24 weeks in patients with major depressive disorder.
RCT (n=122)
Open-label
Computer-generated random numbers
No
Does vortioxetine compared to fluoxetine improve metabolic parameters in patients with major depressive disorder?
In patients with major depressive disorder, one of the antidepressant treatments (Group A) significantly improved metabolic parameters including fasting plasma glucose, HDL, and waist circumference compared to the other (Group B), while both provided similar depression remission.
Absolute Event Rate: 90.8% vs 93.9%
p-value: p=0.003
Background Major depressive disorder (MDD) is a debilitating mood disorder that increases the risk of metabolic syndrome (MS), emphasizing the need for mental and physical health treatments. Although many studies have linked atypical antipsychotics to metabolic disturbances, there is limited evidence linking selective serotonin reuptake inhibitor use to MS. This study aimed to assess the risk of MS among patients with MDD who were administered vortioxetine and fluoxetine. Methodology This was a prospective, open-label, randomized controlled trial conducted in the psychiatry department. Using computer-generated random numbers, the physician assigned fluoxetine 20 mg or vortioxetine 10 mg and recorded MS parameters at baseline and each visit (4, 8, 12, 16, 20, and 24 weeks). This study was registered with CTRI (CTRI/2021/07/034892). Results A total of 122 participants were allocated randomly to the following two groups: group A (n = 60) and group B (n = 62). An independent-sample t-test showed a significant improvement in fasting plasma glucose (FPG) at week eight (p = 0.005), triglycerides (TGs) at week 16 (p = 0.005), high-density lipoprotein (HDL) at week 20 (p = 0.005), and waist circumference at week 24 (p = 0.005) in group A compared to group B. However, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were not significantly associated with either group (p = 0.126 and p = 0.793, respectively). Overall depression remission (Hamilton Depression Rating Scale (HAM-D)) and medication adherence rating scale scores were similar between groups (p = 0.337 and 0.325, respectively). Furthermore, most adverse drug reactions were possibly associated with the study drugs. Conclusions In comparison to group B, group A showed significant improvements in FPG, HDL, and waist circumference more effectively; however, both groups led to higher TG levels, with non-significant numerical improvements observed in SBP and DBP in both groups. In addition, both treatment groups reduced the HAM-D score and had a similar MDD remission rate.
Sankar et al. (Mon,) conducted a rct in Major depressive disorder (n=122). Vortioxetine vs. Fluoxetine 20 mg/day was evaluated on Fasting plasma glucose (FPG) at 24 weeks (mg/dL) (p=0.003). Vortioxetine significantly improved fasting plasma glucose (90.8 vs 93.9 mg/dL, p=0.003) and waist circumference (81.45 vs 84.75 cm, p=0.005) compared to fluoxetine over 24 weeks in patients with major depressive disorder.
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