Trial reportPsychopharmacology2015
A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD.
Trial report in Psychopharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01153009 (A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses), which is not on this map. Cited by 35 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Who cites it
35 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Pooled it
- Systematic Review and Meta-Analysis of Vortioxetine for the Treatment of Major Depressive Disorder in Adults.Frontiers in psychiatry · 2022Pooled it
- Selective publication of antidepressant trials and its influence on apparent efficacy: Updated comparisons and meta-analyses of newer versus older trials.PLoS medicine · 2022Pooled it
- The efficacy and safety of 10 mg/day vortioxetine compared to placebo for adult major depressive disorder: a meta-analysis.African health sciences · 2019Pooled it
- Vortioxetine for depression in adults.The Cochrane database of systematic reviews · 2017Pooled it
- The effect of vortioxetine on overall patient functioning in patients with major depressive disorder.Brain and behavior · 2017Pooled it
- Vortioxetine versus Duloxetine in the Treatment of Patients with Major Depressive Disorder: A Meta-Analysis of Randomized Controlled Trials.Clinical drug investigation · 2016Pooled it
- Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double-blind, randomized, placebo-controlled, Phase 3 clinical trial.Psychiatry and clinical neurosciences · 2026Trial
- Efficacy and Safety of Ammoxetine in Major Depressive Disorder: A Randomized Clinical Trial.JAMA network open · 2025Trial
- A Randomized Controlled Study of Efficacy and Cognitive Function Improvement of Vortioxetine and Escitalopram in Patients with Depression in Chinese Han Nationality.Neuropsychiatric disease and treatment · 2024Trial
- Effectiveness of vortioxetine in patients with major depressive disorder comorbid with generalized anxiety disorder: Results of the RECONNECT study.Journal of psychopharmacology (Oxford, England) · 2022Trial
- Clinical Switching Strategies of Various Antidepressants to Vortioxetine in the PREDDICT Trial.The international journal of neuropsychopharmacology · 2021Trial
- Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: results of an open-label, flexible-dose, 52-week extension study.International clinical psychopharmacology · 2015Trial
- Comparative effectiveness of antidepressants for depression using EHRs from two health systems.BMC psychiatry · 2026Article
- Bayesian Hierarchical Models With Calibrated Mixtures of g-priors for Assessing Treatment Effect Moderation in Meta-Analysis.Statistics in medicine · 2026Article
- Precision Mental Health: Predicting Heterogeneous Treatment Effects for Depression through Data Integration.Journal of the Royal Statistical Society. Series C, Applied statistics · 2025Article
- Review
- Comprehensive analysis of adverse events associated with vortioxetine using the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- The challenges of integrating diverse data sources: A case study in major depression.Health services & outcomes research methodology · 2024Article
- Comparison of methods that combine multiple randomized trials to estimate heterogeneous treatment effects.Statistics in medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationaleVortioxetine has reduced depressive symptoms in adults with major depressive disorder (MDD) in multiple clinical trials.
objectivesThe aim of this study is to evaluate the efficacy, safety, and tolerability of vortioxetine 15 and 20 mg vs placebo in adults with MDD.
methodsPatients were randomized 1:1:1:1 to vortioxetine 15 mg, vortioxetine 20 mg, duloxetine 60 mg (active reference), or placebo. The primary efficacy endpoint was mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 8 (MMRM). Safety/tolerability assessments included physical examinations, vital signs, laboratory evaluations, electrocardiograms, adverse events (AEs), Columbia-Suicide Severity Rating Scale, Arizona Sexual Experiences Scale, and Discontinuation-Emergent Signs and Symptoms checklist.
resultsSix hundred and fourteen patients were randomized. Mean changes in MADRS scores were -12.83 (±0.834), -14.30 (±0.890), -15.57 (±0.880), and -16.90 (±0.884) for placebo, vortioxetine 15 mg (P = .224), vortioxetine 20 mg (P = .023), and duloxetine 60 mg (P < .001) (P vs placebo), respectively. AEs reported by ≥5 % of vortioxetine patients included nausea, headache, diarrhea, dizziness, dry mouth, constipation, vomiting, insomnia, fatigue, and upper respiratory infection. Treatment-emergent sexual dysfunction, suicidal ideation or behavior, and discontinuation symptoms were not significantly different between vortioxetine and placebo.
conclusionsVortioxetine 20 mg significantly reduced MADRS total scores after 8 weeks of treatment. Both vortioxetine doses were well tolerated. CLINICAL
trial registrationClinicalTrials.gov identifier NCT01153009; www.clinicaltrials.gov/ .
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Registered trials
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.