Is vortioxetine (Brintellix) effective in the treatment of major depressive disorder (clinical depression)?

Updated: Aug 06, 2020
  • Author: Jerry L Halverson, MD; Chief Editor: David Bienenfeld, MD  more...
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In September 2013, the FDA approved vortioxetine (Brintellix) for the treatment of major depressive disorder in adults. The drug’s mechanism of action involves enhancement of serotonergic activity through 5-HT reuptake inhibition. It also modulates serotonin receptor activity through 5-HT1A receptor agonism and 5-HT3 receptor antagonism, although the contribution of these activities to the antidepressant effect is not fully understood.

Approval was based on 5 short-term (6-8 week) studies, [105, 106, 107, 108, 109] including one that focused on elderly adults. [109] These studies demonstrated a statistically significant reduction in overall symptoms of depression with vortioxetine compared to placebo, with most consistent results obtained within a dosage range of 15-20 mg/day. Also, a long-term (24-64 week) maintenance study showed a significantly longer time to relapse with vortioxetine compared to placebo. [110, 111] Two studies using lower doses (2.5-5 mg/day) showed no significant difference in efficacy between the drug and placebo. [112, 113] The most common adverse effects were nausea, diarrhea, dry mouth, constipation, vomiting, dizziness, and sexual dysfunction.

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