A pooled analysis of the efficacy of sertraline in women, with a focus on those of childbearing age

Abstract Introduction Gender- and age-specific research on medications is essential for personalizing treatment plans, optimizing dosing, minimizing adverse effects and improving outcomes. Women are twice as likely to be diagnosed with major depressive disorder (MDD), and it is commonly reported dur...

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Main Authors: Andrea Fagiolini, Melissa Paulita Mariano, Egbert Biesheuvel, Pradeep Purushottamahanti
Format: Article
Language:English
Published: BMC 2024-11-01
Series:Annals of General Psychiatry
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Online Access:https://doi.org/10.1186/s12991-024-00519-9
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Summary:Abstract Introduction Gender- and age-specific research on medications is essential for personalizing treatment plans, optimizing dosing, minimizing adverse effects and improving outcomes. Women are twice as likely to be diagnosed with major depressive disorder (MDD), and it is commonly reported during their reproductive years. This post-hoc pooled analysis evaluated the efficacy of sertraline (one of the most studied medications in women) in women of reproductive age (18–44 years). Methods Data was pooled from nine clinical trials of sertraline that included 1832 subjects with MDD. The analysis set included 1097 women, 651 of those were of reproductive age. Sertraline was compared with placebo for changes in total HAM-D17 and CGI scores measured over time through MMRM analysis. The change from baseline to the end of study (-week 8) was assessed using ANCOVA. Results The changes from baseline in total HAM-D17 and CGI scores were significantly higher for sertraline than for placebo at the end of 8 weeks for all women (LS Mean difference, 95% CI: -1.81(-3.01,-0.62), P = 0.0029; -0.38(-0.55,-0.20), P < 0.0001, respectively). For women of reproductive age these changes (LS Mean difference, 95% CI: -2.08(-3.52,-0.64), P = 0.0047; -0.44(-0.66,-0.22), P < 0.0001, respectively), were significant from week 2 (HAM-D17) and week 1 (CGI) till the end of study. Limitations Only sertraline and placebo arms were included in the analysis. The dosing varied between studies, and the effect of dose was not addressed. Conclusions Sertraline is an effective option for treatment of MDD in women, including those in the childbearing age.
ISSN:1744-859X