Real-world effectiveness of vortioxetine in outpatients with major depressive disorder: functioning and dose effects.

BACKGROUND: Functional recovery is an important treatment goal in major depressive disorder (MDD). This study assessed the real-world effectiveness of vortioxetine in patients with MDD, with particular focus on functioning; dose-response was also assessed. METHODS: This was a non-interventional, prospective, multicenter study conducted in Greece. Adult outpatients with MDD (n = 336) initiating vortioxetine (5-20 mg/day flexible dosing) as treatment for a current major depressive episode were followed for 3 months. Analyses were stratified according to vortioxetine dosage at 3 months: 5-10 mg/day versus 15-20 mg/day. Functioning was assessed using the Sheehan Disability Scale (SDS). RESULTS: Mean ± standard error SDS total score decreased (improved) from 18.7 ± 0.3 at baseline to 12.9 ± 0.3 after 1 month of vortioxetine treatment and 7.8 ± 0.4 after 3 months (p < 0.001 vs. baseline for all comparisons). Functional recovery (SDS score ≤ 6) was achieved in 14.6% of patients after 1 month of treatment and 48.4% of patients after 3 months. Improvement from baseline in SDS total and domain scores at 3 months was more pronounced in patients receiving vortioxetine 15-20 mg/day than in those receiving vortioxetine 5-10 mg/day. The mean ± standard error change in SDS total score from baseline was 9.2 ± 0.8 in the 5-10 mg/day group and 12.1 ± 0.4 in the 15-20 mg/day group (p < 0.001). Limitations of this study include its non-interventional study design and lack of a control group or active comparator. CONCLUSIONS: Statistically significant and clinically relevant improvements in functioning were seen in patients with MDD treated with vortioxetine in a real-world setting. Higher doses of vortioxetine were associated with significantly greater improvements in functioning.

Women's Psychiatry.

Brain disorders and mental diseases, in particular, are common and considered as a top global health challenge for the twenty-first century. Interestingly, women suffer more frequently from mental disorders than men. Moreover, women may respond to psychotropic drugs differently than men, and, through their lifespan, they endure sex-orientated social stressors. In this chapter, we present how women may differ in the development and manifestation of mental health issues and how they differ from men in pharmacokinetics and pharmacodynamics. We discuss issues in clinical trials regarding women participation, issues in the use of psychotropic medications in pregnancy, and challenges that psychiatry faces as a result of the wider use of contraceptives, of childbearing at older age, and of menopause. Such issues, among others, demand further women-oriented psychiatric research that can improve the care for women during the course of their lives. Indeed, despite all these known sex differences, psychiatry for both men and women patients uses the same approach. Thereby, a modified paradigm for women's psychiatry, which takes into account all these differences, emerges as a necessity, and psychiatric research should take more vigorously into account sex differences.