Randomized, double‐blind, placebo‐controlled 8‐week trial of the efficacy, safety, and tolerability of 5, 10, and 20 mg/day vortioxetine in adults with major depressive disorder

In a study involving 600 patients, vortioxetine did not show significant differences from placebo in reducing depression symptoms.

• Nominal improvements in depression symptoms were observed with vortioxetine doses of 10 and 20 mg compared to placebo in secondary analyses.
• The 10 mg dose also demonstrated significant effects on response and patient functioning.
• Common side effects included nausea, constipation, dry mouth, dizziness, and insomnia, each occurring at more than twice the rate of placebo.
• Discontinuation symptoms were similar across all treatment groups after one and two weeks post-withdrawal.
• Vortioxetine was well tolerated overall, leading to the suggestion that further studies may be necessary.

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