Effectiveness and Tolerability of Supratherapeutic Dosing of Vortioxetine in Patients With Treatment-Resistant Depression.

Abstract

Objective: To evaluate the effectiveness and tolerability of vortioxetine at supratherapeutic dosages in patients with treatment-resistant depression.Methods: A retrospective observational naturalistic study was conducted in 56 depressed patients resistant to standard care treatment from September 2020 to April 2021. Effectiveness of the vortioxetine treatments was evaluated through Clinical Global Impressions (CGI) score, comparing CGI values at the beginning (T0) of the vortioxetine treatment with CGI values at the earliest of these 2 time points (T1): (1) 8 weeks of treatment with supratherapeutic dosages and (2) day of vortioxetine discontinuation or daily dosage reduction to ≤ 20 mg due to side effects. The tolerability and safe of vortioxetine were also monitored.Results: Fifty-six patients (32 females and 24 males, mean ± SD age of 51.1 ± 9.3 years) were included in the study. Thirty-seven patients received vortioxetine 30 mg/d, while 19 patients were treated with a 40-mg/d dosage. CGI scores significantly decreased (P < .001) in patients treated with 30 mg/d and 40 mg/d, respectively. No severe side effects were reported. Weight gain and nausea were the most common reported side effects. Nausea and limited efficacy were recorded as the most frequent reasons for vortioxetine dose reduction. None of the patients required vortioxetine discontinuation.Conclusions: Supratherapeutic doses of vortioxetine were relatively well-tolerated and effective in patients with treatment-resistant depression.