Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma

Abstract

Background: This analysis investigates the efficacy of vortioxetine in adults with major depressive disorder (MDD) who report childhood or recent trauma.

Methods: Patient-level data were analyzed from 4 double-blind, randomized, placebo-controlled short-term studies investigating the efficacy of vortioxetine (5-20 mg/day) versus placebo in patients (18-75 years old) with DSM-IV-TR-defined MDD. Changes from baseline to week 8 on the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression - Improvement (CGI-I), and Sheehan Disability Scale (SDS) were examined at the individual study level and as in meta-analysis. A long-term relapse prevention study of 5 and 10 mg of vortioxetine was also analyzed. Traumatic events history was recorded at baseline.

Results: Sixty-one percent of subjects (1113/1811) reported trauma history in the short-term studies. A significant effect vs. placebo was observed for vortioxetine on MADRS (10 mg, -2.2, P = .025; 20 mg, -4.4, P < .001), HAM-A (20 mg, -1.60, P = .012), CGI-I (5 mg, -0.3, P = .028; 10 mg, -0.3, P = .013; 20 mg, -0.50, P = .009), and SDS (20 mg, -2.3, P = .007) in patients with any trauma (childhood and/or recent). In the relapse prevention study, 51% (198/392) of subjects reported a history of trauma. Subjects with any trauma (childhood and/or recent) randomized to placebo were significantly more likely to relapse than subjects treated with vortioxetine (hazard ratio 2.8, P = .0019).

Limitations: An exploratory analysis.

Discussion: Vortioxetine showed significant short- and long-term efficacy on depressive and anxiety symptoms and overall functioning in this large subpopulation of MDD patients with a history of trauma. A significantly lower risk of relapse was also observed with vortioxetine.

Trial registration: ClinicalTrials.gov NCT01153009 NCT00635219 NCT01163266 NCT01140906 NCT00596817.

Keywords: Anxiety; Childhood; Depression; Functioning; Trauma; Vortioxetine.

Conflict of interest statement

Declaration of Competing Interest Drs Christensen, Florea, and Loft are employees of H. Lundbeck A/S. Dr. McIntyre has received research grants from the following private industries or nonprofit funds: Stanley Medical Research Institute, National Alliance for Research on Schizophrenia and Depression (NARSAD), and National Institutes of Mental Health. During the past 3 years, Dr McIntyre has received fees for speaking/consultation from Shire, Purdue, Otsuka, Janssen-Ortho, Lundbeck, Pfizer, Neurocrine, Neuralstem, Sunovion, Takeda, and Allergan and research support from Lundbeck, Shire, Purdue, and Allergan. Dr. McIntyre has not received any financial support from H. Lundbeck A/S or other sources for the research presented in this manuscript.

Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.