Effectiveness of vortioxetine in patients with major depressive disorder comorbid with generalized anxiety disorder: Results of the RECONNECT study

Michael Cronquist Christensen, Simon Schmidt, Iria Grande, Michael Cronquist Christensen, Simon Schmidt, Iria Grande

Abstract

Background: Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are frequently comorbid.

Aims: To assess the effectiveness of vortioxetine in patients with MDD and comorbid GAD.

Methods: Open-label, 8-week study (NCT04220996) in 100 adult outpatients with severe MDD and severe comorbid GAD receiving vortioxetine as first treatment for the current depressive episode or switching to vortioxetine due to inadequate response to another drug for depression. Vortioxetine starting dosage was 10 mg/day, with forced up-titration to 20 mg/day after 1 week. Response was defined as ⩾50% decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) and/or Hamilton Anxiety Rating Scale (HAM-A) total score from baseline; remission defined as MADRS and/or HAM-A total score ⩽10.

Results: Clinically meaningful and statistically significant improvements from baseline in symptoms of depression and anxiety, and overall functioning and health-related quality of life, were observed after 8 weeks' vortioxetine treatment (all changes p < 0.0001 vs baseline). At week 8, rates of MADRS response and remission were 61% and 35%, respectively. Corresponding rates of HAM-A response and remission were 55% and 42%. Response on both the MADRS and HAM-A scales was achieved by 52% of patients; 31% achieved remission on both scales. Vortioxetine dose up-titration was well tolerated; no unexpected adverse events were reported.

Conclusion: Vortioxetine demonstrates effectiveness in significantly reducing symptoms of both depression and anxiety in patients with severe MDD comorbid with severe GAD. Findings support increasing vortioxetine dosage to 20 mg/day early in the course of therapy, and show that this may be achieved without compromising tolerability.

Keywords: Major depressive disorder; dosage; effectiveness; generalized anxiety disorder; tolerability; vortioxetine.

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: M.C.C. and S.S. are employees of H. Lundbeck A/S. I.G. is an adviser, consultant and/or speaker for Lundbeck, Otsuka, Angelini, Casen Recordati, Ferrer and Janssen Cilag, and has received research funding from the Instituto de Salud Carlos III, Ministry of Economy and Competitiveness, Spain.

Figures

Figure 1.
Figure 1.
Panels (a) to (e): LS mean (SE) change from baseline for (a) MADRS total score, (b) HAM-A total score, (c) HADS-D subscale score, (d) HADS-A subscale score and (e) CGI-S score; panel (f): LS mean (SE) CGI-I score (full analysis set). For panels (a) to (e), p-values are at week 8 vs baseline; for panel (f), p-value is at week 8 based on a test of CGI-I score = 4 (no improvement). CGI-I: Clinical Global Impression–Improvement; CGI-S: Clinical Global Impression–Severity; HADS-A: Hospital Anxiety and Depression Scale–Anxiety; HADS-D: Hospital Anxiety and Depression Scale–Depression; HAM-A: Hamilton Anxiety Rating Scale; LS: least-squares; MADRS: Montgomery–Åsberg Depression Rating Scale; SE: standard error.
Figure 2.
Figure 2.
FAST total and domain scores at baseline and change (SE) from baseline after 8 weeks of treatment with vortioxetine (full analysis set; patients with a corresponding baseline score). p < 0.0001 for all changes from baseline. FAST: Functioning Assessment Short Test; CFB: change from baseline; SE: standard error.
Figure 3.
Figure 3.
Q-LES-Q long-form domain scores at baseline and change (SE) from baseline after 8 weeks of treatment with vortioxetine (full analysis set, patients with a corresponding baseline score). The Q-LES-Q numerical scale has been converted into a percentage scale by linear transformation of the scores into a scale of 0–100, where 0 corresponds to the worst score and 100 to the best score on the numerical scale. p < 0.0001 for all changes from baseline. CFB: change from baseline; Q-LES-Q long-form: Quality of Life Enjoyment and Satisfaction Questionnaire long-form; SE: standard error.

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