Perinatal Mood and Anxiety Disorders in Women Undergoing Medically Assisted Reproduction

Background: Women taking advantage of medically assisted reproduction (MAR) techniques may differ from spontaneously conceiving women (nonMAR) in risk of depression and/or anxiety. We aimed to investigate possible differences between MAR and nonMAR through the use of the Edinburgh Postnatal Depression Scale in a sample of Italian-speaking women at their third trimester of pregnancy. Methods: We administered the Edinburgh Postnatal Depression Scale (EPDS) to two groups of pregnant women, MAR and nonMAR, at the third trimester of pregnancy (T0), one month after delivery (T1), and three months after delivery (T2) from February 2013 to December 2019. EPDS total scores cutoffs were ≥9 for risk of depression, 9–11 mild depression, ≥12 major depression, and the EPDS-3A cluster ≥4 was a proxy for anxiety. Results: Included were 1303 nonMAR women and 92 MAR, an expected disproportion. NonMAR and MAR women did not differ on depression or anxiety at any assessment timepoint. MAR women were older than nonMAR, consumed more alcohol and medical drugs, and displayed more complications during pregnancy. Scoring over the threshold on depression risk was associated with foreign nationality, unemployment, psychiatric history of the patient, family or partner, psychiatric problems in past pregnancies, hyperemesis, premenstrual syndrome (PMS), and stressful life events in the last year at baseline, and, for some of them, at other timepoints. In contrast, MAR past or current was associated with having suprathreshold depression at the first-month postpartum follow-up. Conclusions: Taken together, our data show that women opting for MAR do not differ from spontaneously conceiving women regarding psychiatric outcomes but do differ on some sociodemographic and clinical variables

Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trialResearch in context

Summary: Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01–2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. Funding: The study was funded by the Italian Medicines Agency within the “2016 Call for Independent Drug Research”