The Effects of Vortioxetine on Cognitive Dysfunction in Patients With Inadequate Response to Current Anti-Depressants in Major Depressive Disorder: A Short-Term, Randomized, Double-Blind, Exploratory Study versus Escitalopram

December 21, 2017
Download Poster (623.11 KB)

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Background. Major Depressive Disorder (MDD) is a complex disease characterized by emotional, physical and cognitive symptoms. This study explored the effects of vortioxetine versus escitalopram on outcomes of cognition, functioning and mood symptoms in depressed patients with inadequate response to current antidepressant treatment.

Methods. In this parallel-group, active-comparator study, adult patients (18-65 years, N = 101) with MDD, who responded inadequately to current antidepressant monotherapy were randomized 1:1 to 8 weeks of double-blind treatment with flexible doses (10 to 20mg/day) of either vortioxetine or escitalopram. Primary and key secondary efficacy measures, respectively, were the Digit Symbol Substitution Test (DSST), analyzed using a mixed model for repeated measurements, and the University of San Diego Performance-based Skills Assessment - Brief (UPSA-B), analyzed using analysis of covariance (last observation carried forward method).

Results. At week 8, improvements relative to baseline in DSST and UPSA-B performance were seen among patients in both treatment groups, with no statistically significant treatment differences. Numerical improvements across measures of cognition, functioning and mood symptoms generally favored vortioxetine. The majority of adverse events were mild or moderate, with nausea being the most common adverse event.

Conclusion. Although this exploratory study did not meet primary and key secondary endpoints of DSST and USPA-B, the results support vortioxetine in doses of 10 to 20 mg/day as an efficacious and well-tolerated antidepressant switch treatment. Moreover the results across cognition endpoints support previous data that vortioxetine improves the cognitive function in MDD.

Eduard Vieta, MD; Lasse B. Sluth, Cand.Scient.; Christina K. Olsen, PhD
Sponsoring Organization: 
Takeda Pharmaceuticals U.S.A., Inc., and H. Lundbeck A/S
Mood Disorders