Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability

Background: Patients with major depressive disorder (MDD) often experience comorbid anxiety symptoms. Vortioxetine has demonstrated efficacy in treating anxiety symptoms in patients with MDD; however, efficacy and tolerability have not been assessed across the entire approved dosage range.Methods: The efficacy and tolerability of vortioxetine 5-20 mg/day were assessed in patients with MDD and high levels of anxiety symptoms (Hamilton Anxiety Rating Scale [HAM-A] total score >= 20) using pooled data from four randomized, fixed-dose, placebo-controlled studies (n = 842). Data from a randomized, double-blind study of vortioxetine 10-20 mg/day versus agomelatine 25-50 mg/day in patients with an inadequate response to prior therapy (n = 299) were analyzed separately. Mean changes from baseline in Montgomery-Asberg Depression Rating Scale (MADRS), HAM-A, and Sheehan Disability Scale (SDS) total scores were analyzed by vortioxetine dosage.Results: The pooled analysis of fixed-dose studies demonstrated a clear dose-response relationship for vortiox-etine 5-20 mg/day for improvements in MADRS, HAM-A, and SDS total scores. Vortioxetine 20 mg/day demonstrated significant effects versus placebo from week 4 onwards. In the post-hoc analysis of the active -controlled study in patients with an inadequate response to prior therapy, vortioxetine 10-20 mg/day was su-perior to agomelatine across all outcome measures from week 4 onwards. Up-titration of vortioxetine to 20 mg/day was not associated with an increase in adverse events. Limitations: Short-term trials.Conclusions: Vortioxetine is efficacious and well tolerated in patients with MDD and high levels of anxiety symptoms, including those with an inadequate response to prior therapy. The greatest therapeutic benefits were observed with vortioxetine 20 mg/day.Trial registration: NCT01140906, NCT01153009, NCT01163266, NCT01255787, NCT01488071.

Automated summary

This study assessed the efficacy and tolerability of Vortioxetine in treating anxiety symptoms in patients with major depressive disorder. The results showed a clear dose-response relationship for Vortioxetine in improving depressive, anxiety, and functioning symptoms. Additionally, Vortioxetine was found to be superior to agomelatine in patients with an inadequate response to prior therapy.