The analyses included all 11 short-term (6 or 8 weeks), double-blind, randomized, fixed-dose, placebo-controlled studies conducted by Takeda/Lundbeck that investigated the efficacy of vortioxetine (5–20 mg/day) for the treatment of MDD and which included MADRS and Sheehan Disability Scale (SDS) assessments. All studies were conducted in adult patients with a primary diagnosis of single-episode or recurrent MDD according to Diagnostic and Statistical Manual of Mental Disorders (4th Edition, Text Revision) criteria.35 Additional eligibility criteria of individual studies are summarized in Table 1.

Key Inclusion Criteria for the Placebo-Controlled Trials

Abbreviations: MADRS, Montgomery–Åsberg Depression Rating Scale; MDE, major depressive episode.

Data were also analyzed from a short-term (12-week), randomized, active-controlled trial of flexible-dose treatment with vortioxetine (10–20 mg/day) compared with agomelatine (25–50 mg/day) in patients with MDD who had an inadequate response to SSRI/SNRI monotherapy (NCT01488071).47 This study was included as agomelatine was shown to be effective for the treatment of anhedonia (assessed by SHAPS total score) in patients with MDD in an 8-week, open-label trial.48 Only patients with depressive symptoms considered nonresponsive or partially responsive to a single SSRI/SNRI treatment course of an adequate dose (approved) and duration (≥6 weeks) were eligible for this study. Other key eligibility criteria were duration of current major depressive episode <12 months, and MADRS total score ≥22 and MADRS item 1 (apparent sadness) score ≥3 at screening and baseline visits. Following a screening period of 4–10 days, eligible patients were switched from their previous treatment for 12 weeks of double-blind treatment with either vortioxetine or agomelatine. During the first 4 weeks of the study, vortioxetine and agomelatine doses were individually adjusted according to the investigator’s clinical judgment. After week 4, doses were fixed.

All studies included in this analysis were conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines and were approved by the necessary research ethics committees. Patients provided written informed consent for participation. Further ethical approval was not required for this pooled analysis, as it used data from studies that have already been published.

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