A Randomized Controlled Trial Comparing the Effects of Vilazodone, Escitalopram, and Vortioxetine Monotherapy on the Metabolic Parameters in Patients With Major Depressive Disorder.

BACKGROUND AND OBJECTIVES

The coexistence of major depressive disorder (MDD) and metabolic illness could culminate in an aberrant metabolic profile. Individuals with MDD and type 2 diabetes mellitus (T2DM) are more likely to have impaired metabolic indicators. Effective antidepressant therapy can alleviate depressive symptoms and metabolic abnormalities. We focused on the effects of vilazodone, escitalopram, and vortioxetine on metabolic indices. Our research aimed to examine changes after 16 weeks of intervention in the glycemic indices, serum creatinine, lipid profile, hepatic parameters, and the Hamilton Depression Rating Scale (HDRS) 17-item version.

METHODS

A three-arm, randomized, open-label trial with 96 MDD patients was executed. Participants were divided into three distinct groups in a 1:1:1 ratio for 16 weeks and issued tablets of vilazodone (20-40 mg/day), escitalopram (10-20 mg/day), or vortioxetine (5-20 mg/day). Vilazodone and vortioxetine were the two test medications, while escitalopram served as the control. We stratified the participants as non-diabetics and diabetics. Follow-up appointments were slated four weeks after the initial visit. HDRS scores and other metabolic indicators were assessed at each visit in the per-protocol (PP) population. After 12 weeks, glycated hemoglobin (HbA) levels were measured. Lower HDRS scores indicated that depression-related symptoms had improved. We investigated the relationship between the 16-week differences in the fasting blood sugar (FBS) and HDRS scores. The Kruskal-Wallis test, Bonferroni correction, and Pearson correlation were all used in our analysis. We registered our trial prospectively in the Clinical Trial Registry of India (CTRI) (2022/07/043808).

RESULTS

Of the 134 people we screened, 119 (81.34%) were deemed eligible. The PP population included 96 (88.07%) of those who completed the 16-week study. The population's average age was 46.3 ± 6.2 years. Across all study groups, the median baseline HDRS score was 30.0 (p = 0.964). At 16 weeks, the equivalent scores dropped to 15.0, 14.0, and 13.0 (p = 0.002). The median FBS levels at baseline and 16 weeks were 100.5, 104.0, and 98.0 (p = 0.491) and 91.5, 98.5, and 91.5 (p = 0.561), respectively. The post hoc analysis manifested no statistically significant changes between any parameters. Except for the reductions in glycemic indices in diabetic patients, no other data differed significantly. There was a positive relationship between FBS and HDRS scores.

CONCLUSION

Irrespective of the diabetic situation, all three drugs substantially lowered HDRS scores. People with diabetes experienced noticeable declines in glycemic indices. Despite this, the patients' other metabolic indicators showed no significant alterations. We urge additional research with a larger sample size to investigate these medications' long-term impact on various metabolic indicators.