CNSPulse
T102

PREGNANCY OUTCOMES AFTER FIRST-TRIMESTER EXPOSURE TO VORTIOXETINE: PROSPECTIVE OUTCOMES FROM THE MGH NATIONAL PREGNANCY REGISTRY FOR PSYCHIATRIC MEDICATIONS

Marlene Freeman — Adele Viguera2, Ana Manuelian1, Emma Grassi1, Bridget Murphy1, Lee Cohen1 1Massachusetts General Hospital, Ammon-Pinizzotto Center for Women's Mental Health, 2Massachusetts General Hospital, Ammon-Pinizzotto Center for Women's Mental Health, Cleveland Clinic, Cleveland Clinic Neurological Institute

2026 ASCP Annual Meeting

Purpose

Vortioxetine is an antidepressant used to treat major depressive disorder (MDD), a disorder that is common among women of reproductive age. To date, the reproductive safety of vortioxetine in humans has been limited. We sought to provide preliminary systematic data from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications (NPRPM) on the risk of major malformations after exposure to vortioxetine in the first trimester of pregnancy.

Methods

The NPRPM is a longitudinal ongoing study in which pregnant women with psychiatric disorders are enrolled to prospectively assess for major congenital malformations after in utero exposure to psychotropics. Data regarding women who took vortioxetine during the first trimester were extracted from the NPRPM database. Data for this analysis were assessed as a rigorously ascertained case series to determine the incidence of major malformations. The primary outcome of major malformations following first trimester exposure was obtained by maternal postpartum interview and medical record review.

Results

As of November 14, 2025, n=54 women who reported taking vortioxetine during the first trimester had evaluable data. Among this sample, there were no major malformations.

Conclusions

These preliminary data represent the only rigorous and prospectively ascertained pregnancy outcomes after first trimester vortioxetine exposure. No major malformations were observed. While these data are reassuring, the relatively small sample size limits conclusions on the safety of vortioxetine in pregnancy.