J Affect Disord. 2025 Oct 27:120562. doi: 10.1016/j.jad.2025.120562. Online ahead of print.
ABSTRACT
BACKGROUND: Vortioxetine, a multimodal antidepressant, has been extensively documented for its efficacy and safety. The medication is typically well tolerated, with nausea being the most common adverse effect. Gradual titration with the oral solution may further enhance the medication’s tolerability.
METHODS: This retrospective, uncontrolled multicenter study evaluated 188 adult patients with major depressive disorder (MDD) who were treated with vortioxetine oral drop solutions. Patients initiated treatment with vortioxetine at a dosage of one or two drops per day (equivalent to 1 mg or 2 mg, respectively) and underwent a gradual increase in dosage, with each subsequent dose increased by one or two drops, up to the target dose. The subjects were observed for a minimum of eight weeks. The primary objective was to assess tolerability, with particular attention paid to the incidence and progression of nausea. The efficacy of the treatment was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression (CGI) scale at the outset of the study and at weeks 1, 2, 4, and 8. Adverse events were recorded through patient reports at weeks 1, 2, 4, and 8 and documented by clinicians.
RESULTS: The administration of vortioxetine following a slow titration treatment protocol was found to markedly reduce the prevalence of nausea observed in 9.6 % of patients at week 1, 5.9 % at week 2, 2.7 % at week 4, and 1.7 % at week 8. The incidence of other adverse events exhibited a comparable decline over time. Despite the gradual dosing approach, patients exhibited a progressive improvement in their clinical status, as evidenced by a reduction in MADRS scores from a mean of 29.22 (SD 7.71) at baseline to 11.89 (SD 6.35) at week 8. At the end of the treatment period, 72 % of patients were classified as good responders for MADRS and 71 % for CGI (change ≥50 %) while 46 % achieved remission according to MADRS criteria (MADRS ≤10).
CONCLUSIONS: In our cohort, the slow titration of vortioxetine oral drop solutions resulted in an enhancement in tolerability, accompanied by a decline in nausea compared to the rates documented in prior studies utilizing standard tablet formulations. This approach did not compromise the efficacy of the treatment. This flexible titration strategy represents a promising approach to the mitigation of adverse effects while maintaining clinical effectiveness. Further research should be conducted to investigate the long-term benefits of this method and to compare it to other titration protocols.
PMID:41161537 | DOI:10.1016/j.jad.2025.120562
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