ArticleJournal of psychopharmacology (Oxford, England)2016
The safety and tolerability of vortioxetine: Analysis of data from randomized placebo-controlled trials and open-label extension studies.
Article in Journal of psychopharmacology (Oxford, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 7 of them syntheses that pooled it.
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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.
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Who cites it
74 citing papers in PubMed, 7 syntheses or guidelines pooled it, 185 citations in OpenAlex.
- Depressive disorders: systematic review of approved psychiatric medications (2009-April 2025) and pipeline phase 3 medications.BMC psychiatry · 2025Pooled it
- Deprescribing Antidepressants in Children and Adolescents: A Systematic Review of Discontinuation Approaches, Cross-Titration, and Withdrawal Symptoms.Journal of child and adolescent psychopharmacology · 2025Pooled it
- Pooled it
- Effect of Vortioxetine on Cognitive Impairment in Patients With Major Depressive Disorder: A Systematic Review and Meta-analysis of Randomized Controlled Trials.The international journal of neuropsychopharmacology · 2022Pooled it
- Systematic Review and Meta-Analysis of Vortioxetine for the Treatment of Major Depressive Disorder in Adults.Frontiers in psychiatry · 2022Pooled it
- Efficacy of vortioxetine on the physical symptoms of major depressive disorder.Journal of psychopharmacology (Oxford, England) · 2018Pooled it
- Vortioxetine for depression in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Vortioxetine for the Treatment of Depression in Patients with Parkinson's Disease: A 16-week Pilot, Prospective, Open-label Safety Study.Current neuropharmacology · 2026Trial
- 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
- Clinical efficacy and safety of vortioxetine as an adjuvant drug for patients with bipolar depression.Journal of Zhejiang University. Science. B · 2025Trial
- Clinical benefits and bioequivalence of vortioxetine oral drop solution versus oral tablets.Journal of psychopharmacology (Oxford, England) · 2024Trial
- Vortioxetine vs. Other Antidepressants in Patients with Major Depressive Episode With or Without Substance Use Disorder.Current neuropharmacology · 2021Trial
- Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study.International clinical psychopharmacology · 2020Trial
- 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
- Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 2-week, randomized, double-blind, placebo-controlled study.International clinical psychopharmacology · 2019Trial
- A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with Depressive or Anxiety Disorders.Journal of child and adolescent psychopharmacology · 2018Trial
- Real-World Vortioxetine Prescription for Patients With Major Depressive Disorder in Japan: A Retrospective Cohort Study Using a Japanese Health Insurance Claims Database.Neuropsychopharmacology reports · 2026Article
- Comparative Sleep Architecture Profiles of Antidepressants in Mice: Pharmacological Characterization of Paroxetine, Sertraline, Duloxetine, Mirtazapine and Vortioxetine.Pharmacology research & perspectives · 2026Article
- Effectiveness and Tolerability of Vortioxetine in Major Depressive Disorder: A Real-World Study in Switzerland.Clinical drug investigation · 2026Observational
- Vortioxetine mitigates methotrexate-induced oral mucosa injury via sirtuin 1 pathway and intrinsic apoptosis signaling.BMC oral health · 2026Article
14 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The safety and tolerability of vortioxetine in adults with major depressive disorder was assessed. Tolerability was based on the nature, incidence and severity of treatment-emergent adverse events (TEAEs) during acute (6/8) week treatment in 11 randomized, double-blind placebo-controlled short-term studies in major depressive disorder: six with an active reference. Symptoms following discontinuation were assessed through the Discontinuation-Emergent Signs and Symptoms checklist in three studies. Long-term (⩽52 weeks) tolerability was evaluated in five open-label extension studies. Patients (n =5701) were acutely treated with either placebo (n=1817), vortioxetine (5-20mg/day; n=3018), venlafaxine XR (225mg/day; n=113) or duloxetine (60mg/day; n=753). The withdrawal rate due to TEAEs during treatment with vortioxetine (5-20mg/day) was 4.5-7.8%, compared with placebo (3.6%), venlafaxine XR (14.2%) or duloxetine (8.8%). Common TEAEs (incidence ⩾5% and >2 × placebo) with vortioxetine (5-20mg/day) were nausea (20.9-31.2%) and vomiting (2.9-6.5%). For vortioxetine (5-20mg/day), the incidence of TEAEs associated with insomnia was 2.0-5.1% versus 4.0% for placebo, and with sexual dysfunction 1.6-1.8% versus 1.0% for placebo. Discontinuation symptoms as assessed by the mean Discontinuation-Emergent Signs and Symptoms total score after abrupt discontinuation were comparable to placebo in the first and second week. Vortioxetine had no effect relative to placebo on clinical laboratory parameters, body weight, heart rate or blood pressure. Vortioxetine showed no clinically relevant effect on ECG parameters, including the QTcF interval. In long-term treatment, no new types of TEAEs were seen; the mean weight gain was 0.7-0.8kg. Thus, vortioxetine (5-20mg/day) appears safe and generally well tolerated in the treatment of major depressive disorder.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.