Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 5 mg, 10 mg, 15 mg, 20 mg) |
Drug Class | Antidepressants |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of major depressive disorder (MDD) in adults.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Trintellix (vortioxetine) Prescribing Information. | 2023 | Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Nonpharmacologic and pharmacologic treatments of adults in the acute phase of major depressive disorder: a living clinical guideline from the American College of Physicians. | 2023 | Annals of Internal Medicine |
VA/DoD clinical practice guideline for the management of major depressive disorder. | 2022 | Department of Veterans Affairs: Department of Defense |
The 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders. | 2020 | Australian & New Zealand Journal of Psychiatry |