SynthesisSystematic reviews2015
The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: a systematic review and meta-analysis.
Synthesis in Systematic reviews, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Vortioxetine for depression in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies.European child & adolescent psychiatry · 2025Trial
- Randomized, double-blind, placebo-controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder.Psychiatry and clinical neurosciences · 2020Trial
- Trial
- Emotional Blunting in Hong Kong Patients with Major Depressive Disorder Treated with Vortioxetine: A Naturalistic Observational Study.Biomedicines · 2026Article
- Post-market safety profile and suicide risk signals of vortioxetine: a real-world pharmacovigilance study.Frontiers in pharmacology · 2026Article
- Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study.JAACAP open · 2025Article
- Post-marketing safety surveillance of vortioxetine hydrobromide: a pharmacovigilance study leveraging FAERS database.Frontiers in psychiatry · 2025Article
- Analytically Confirmed Intentional Overdose of the Antidepressant Vortioxetine.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2024Article
- Εfficacy and safety of vortioxetine (Lu AA21004) in the treatment of adult patients with major depressive disorder: A systematic review and a meta‑analysis of randomized controlled trials.Experimental and therapeutic medicine · 2023Article
- The efficacy of psychotherapies and pharmacotherapies for mental disorders in adults: an umbrella review and meta-analytic evaluation of recent meta-analyses.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2022Article
- Duloxetine versus 'active' placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.Systematic reviews · 2021Article
- Vortioxetine as a new frontier in the treatment of chronic neuropathic pain: a review and update.Therapeutic advances in psychopharmacology · 2021Review
- Antidepressant effect ofThe Libyan journal of medicine · 2020Article
- The Role of Norepinephrine and Its α-Adrenergic Receptors in the Pathophysiology and Treatment of Major Depressive Disorder and Schizophrenia: A Systematic Review.Frontiers in psychiatry · 2017Review
- Multimodal antidepressant vortioxetine causes analgesia in a mouse model of chronic neuropathic pain.Molecular painArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVortioxetine is the first mixed serotonin agonist and antagonist antidepressant approved in the US. We sought to evaluate all published and unpublished data available to determine the efficacy and harms of vortioxetine in adults with major depressive disorder.
methodsWe used a predefined search strategy of MEDLINE, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Drugs@FDA to identify studies evaluating vortioxetine in the acute treatment of major depressive disorder. Only randomized controlled trials (RCTs) that provided results on relevant clinical efficacy and safety outcomes were included. Study quality was assessed and results were pooled using mixed effect meta-analyses where applicable.
resultsWe identified 11 RCTs with 6,145 participants meeting inclusion criteria (eight were published and three were unpublished). The trials did not exceed 8 weeks in duration. The response rate with vortioxetine was significantly higher for 1-mg (relative risk (RR) = 1.91; 95% confidence interval (CI) 1.36 to 2.69), 5-mg (RR = 1.33; 95% CI 1.10 to 1.61), 10-mg (RR = 1.42; 95% CI 1.21 to 1.67), and 20-mg doses (RR = 1.58; 95% CI 1.19 to 2.08) compared to placebo. Remission rates were significantly higher for the 10-mg group (RR = 1.45; 95% CI 1.18 to 1.77) and the 20-mg group (RR = 1.68; 95% CI 1.19 to 2.37) compared to placebo. Meta-regression of dose on the log odds ratio of response was not statistically significant (β = 0.01; P = 0.46). Vortioxetine response rates were lower than active serotonin and norepinephrine reuptake inhibitor (SNRI) comparators for the 5-mg (RR = 0.88; 95% CI 0.80 to 0.98), 15-mg (RR = 0.78; 95% CI 0.68 to 0.90), and 20-mg (RR = 0.82; 95% CI 0.72 to 0.94) doses. The most common adverse events were nausea and vomiting which increased in frequency with higher doses.
conclusionsVortioxetine was significantly more effective than placebo for acute treatment of major depressive disorder (MDD). Although treatment effect estimates varied substantially between studies, a dose effect was not observed. Vortioxetine does not appear to be more effective, and is potentially less effective, than an SNRI. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42013006198 .
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