A meta-analysis of randomized, placebo-controlled trials of vortioxetine for the treatment of major depressive disorder in adults
| Autor: | Marianne Dragheim, Atul R. Mahableshwarkar, Henrik Loft, Eduard Vieta, Michael E. Thase |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
medicine.medical_specialty Clinical Neurology Major depressive disorder Sulfides Placebo Piperazines 03 medical and health sciences 0302 clinical medicine Primary outcome Recurrence Rating scale Internal medicine medicine Humans Pharmacology (medical) Drug dose–response relationship Psychiatry Biological Psychiatry Randomized Controlled Trials as Topic Psychiatric Status Rating Scales Pharmacology Response rate (survey) Vortioxetine Depressive Disorder Major Dose-Response Relationship Drug medicine.disease Clinical efficacy 030227 psychiatry Meta-analysis Psychiatry and Mental health Treatment Outcome Neurology Antidepressant Neurology (clinical) Psychology Selective Serotonin Reuptake Inhibitors 030217 neurology & neurosurgery |
| Zdroj: | European Neuropsychopharmacology. 26:979-993 |
| ISSN: | 0924-977X |
| DOI: | 10.1016/j.euroneuro.2016.03.007 |
| Popis: | The efficacy and safety of vortioxetine, an antidepressant approved for the treatment of adults with major depressive disorder (MDD), was studied in 11 randomized, double-blind, placebo-controlled trials of 6/8 weeks׳ treatment duration. An aggregated study-level meta-analysis was conducted to estimate the magnitude and dose-relationship of the clinical effect of approved doses of vortioxetine (5–20mg/day). The primary outcome measure was change from baseline to endpoint in Montgomery–Åsberg Depression Rating Scale (MADRS) total score. Differences from placebo were analyzed using mixed model for repeated measurements (MMRM) analysis, with a sensitivity analysis also conducted using last observation carried forward. Secondary outcomes included MADRS single-item scores, response rate (≥50% reduction in baseline MADRS), remission rate (MADRS ≤10), and Clinical Global Impressions scores. Across the 11 studies, 1824 patients were treated with placebo and 3304 with vortioxetine (5mg/day: n=1001; 10mg/day: n=1042; 15mg/day: n=449; 20mg/day: n=812). The MMRM meta-analysis demonstrated that vortioxetine 5, 10, and 20mg/day were associated with significant reductions in MADRS total score (Δ-2.27, Δ-3.57, and Δ-4.57, respectively; p |
| Databáze: | OpenAIRE |
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