Vortioxetine

(Trintellix®)

Vortioxetine

Drug updated on 12/11/2024

Dosage FormTablet (oral; 5 mg, 10 mg, 15 mg, 20 mg)
Drug ClassAntidepressants
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of major depressive disorder (MDD) in adults.

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Summary
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  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • Vortioxetine significantly reduced depressive symptoms and improved cognitive function in adults with major depressive disorder (MDD) at doses of 5-20 mg, with notable improvements in Montgomery-Asberg Depression Rating Scale (MADRS), Sheehan Disability Scale (SDS), Clinical Global Impression Scale-Improvement (CGI-I), and Digit Symbol Substitution Test (DSST) scores, especially at 10 and 20 mg.
  • Compared to placebo, vortioxetine demonstrated higher response and remission rates and enhanced cognitive function, with no significant differences in efficacy compared to serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs).
  • In patients with comorbid cardiovascular disease or diabetes, vortioxetine use resulted in significant reductions in MADRS scores, supporting its efficacy in MDD populations with specific comorbidities.
  • Limited evidence suggests potential cognitive benefits for older adults with depressive symptoms, while efficacy in children and adolescents remains uncertain due to low-certainty evidence.
  • The most common adverse events associated with vortioxetine were nausea, hyperhidrosis, insomnia, and vomiting, with adverse events increasing at higher doses. Nausea was the most frequently reported in real-world data, with an estimated rate of 8.9%.
  • Compared to SNRIs, vortioxetine demonstrated better tolerability without significant differences in response or remission rates. No significant differences in response or remission rates were observed compared to SSRIs, though vortioxetine had a higher incidence of nausea/vomiting than placebo.
  • In specific populations, none of the six hospitalized patients developed serious safety issues, with only one case of mild-to-moderate nausea reported. For patients with comorbid cardiovascular disease or diabetes, the safety profile of vortioxetine aligned with expected treatment outcomes, without unexpected adverse events.

Product Monograph / Prescribing Information

Document TitleYearSource
Trintellix (vortioxetine) Prescribing Information.2023Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effect of antidepressants on ejaculation dysfunction in patients with depression and anxiety: A systematic review and network meta-analysis2024Andrology
Vortioxetine for depression in adults: A systematic review and dose-response meta-analysis of randomized controlled trials2024Psychiatry And Clinical Neurosciences
The Role of Vortioxetine in the Treatment of Depressive Symptoms in General Hospital Psychiatry: A Case-Series and PRISMA-Compliant Systematic Review of the Literature2024Journal Of Clinical Medicine
Epsilonfficacy 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 trials2023Experimental And Therapeutic Medicine
Effectiveness and Safety of Vortioxetine for the Treatment of Major Depressive Disorder in the Real World: A Systematic Review and Meta-Analysis2023The International Journal Of Neuropsychopharmacology
Antidepressants for the treatment of adults with major depressive disorder in the maintenance phase: a systematic review and network meta-analysis2023Molecular Psychiatry
Individualized antidepressant therapy in patients with major depressive disorder: Novel evidence-informed decision support tool2022Canadian Family Physician Medecin De Famille Canadien
Effect of Vortioxetine on Cognitive Impairment in Patients With Major Depressive Disorder: A Systematic Review and Meta-analysis of Randomized Controlled Trials2022The International Journal Of Neuropsychopharmacology
Systematic Review and Meta-Analysis of Vortioxetine for the Treatment of Major Depressive Disorder in Adults2022Frontiers In Psychiatry
Efficacy and safety of vortioxetine in treatment of patients with major depressive disorder and common co-morbid physical illness2022Journal Of Affective Disorders
Cognitive effects of vortioxetine in older adults: a systematic review2021Therapeutic Advances In Psychopharmacology
New generation antidepressants for depression in children and adolescents: a network meta-analysis2021The Cochrane Database Of Systematic Reviews
Procognitive Effects of Antidepressants and Other Therapeutic Agents in Major Depressive Disorder: A Systematic Review2020The Journal Of Clinical Psychiatry

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