A naturalistic, 24-week, open-label, add-on study of vortioxetine in bipolar depression.

Marcin Siwek,Dominika Dudek,Janusz Rybakowski,Adrian Chrobak,Zbigniew Sołtys,Anna Krupa

doi:10.12740/pp/onlinefirst/132962

Marcin Siwek, Dominika Dudek + Show 4 more

Open Access

https://doi.org/10.12740/pp/onlinefirst/132962

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Journal: Psychiatria polska	Publication Date: Jun 30, 2022
Citations: 3	License type: CC BY 4.0

Abstract

The efficacy of vortioxetine in major depressive disorder has been evaluated in many studies. However, there is a lack of studies assessing vortioxetine in bipolar depression. In 60 patients with bipolar depression, vortioxetine 10-20 mg daily was added to current mood stabilizing medication during 24-week, naturalistic, openlabel study. The most frequent mood stabilizers were lamotrigine, quetiapine, olanzapine, and valproates. The therapeutic efficacy was evaluated by the Clinical Global Impression - Improvement (CGI-I) and Clinical Global Impression - Severity (CGI-S) scales. Patients were classified as responding to vortioxetine when they achieved 1 or 2 points on the CGI-I scale at any stage of observation. The criterion of remission was defined as score 1 at the CGI-S. 73% of all patients (44/60) responded to vortioxetine and 52% (31/60) achieved clinical remission of depressive symptoms (in mean 8.97 ± 4.05 weeks). There were no significant associations between vortioxetine response/remission rates and: (1) the dose, (2) BD type, (3) clinical stage, (4) presence of rapid cycling, (5) history of psychotic symptoms, analyzed depressive symptoms, and (6) concomitantly used mood stabilizer. 4 patients (6.7%) stopped treatment due to adverse effects (nausea), and 7 patients (11.7%) discontinued treatment due to the phase switch. 14 patients (23%) experienced a loss of vortioxetine effectiveness after the initial response or remission. The results indicate relatively high rates of response and remission during 24-week treatment in depressed bipolar patients receiving vortioxetine concomitantly with a mood stabilizer. This may indicate that vortioxetine added to a mood stabilizer may constitute an efficient and well tolerated therapeutic option in bipolar depression.

Highlights

Vortioxetine is a novel multimodal antidepressant drug approved by the Food and Drug Administration in 2013
The results indicate relatively high rates of response and remission during 24-week treatment in depressed bipolar patients receiving vortioxetine concomitantly with a mood stabilizer
This may indicate that vortioxetine added to a mood stabilizer may constitute an efficient and well tolerated therapeutic option in bipolar depression

Summary

Introduction

Vortioxetine is a novel multimodal antidepressant drug approved by the Food and Drug Administration in 2013. Short – and long-term clinical trials have shown its efficacy in the treatment of moderate to severe major depressive disorder, in doses of 5-20 mg/ day [3]. Very low indices of drug discontinuation due to the side effects in open-label extension studies have been shown [4]. Some studies and analyses indicate that cautious short-term treatment with antidepressants combined with mood stabilizing treatment may be useful for bipolar depression without concurrent agitation or hypomanic symptoms [6,7,8,9]. Due to the high prevalence of treatment-resistance in bipolar depression, there is a need for evaluating the effects of novel treatment strategies, including antidepressant drugs with novel mechanisms of action

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