Maternal Exposure to Antidepressants and Psychiatric Outcomes Among Offspring in a National Birth Cohort (Prenatal SSRIs and offspring Psychiatric Outcome)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33120
• EU PAS number:
  EUPAS33119
• Study ID:
  33120
• Official title and acronym:
  Maternal Exposure to Antidepressants and Psychiatric Outcomes Among Offspring in a National Birth Cohort (Prenatal SSRIs and offspring Psychiatric Outcome)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  The overall objective of this project is to address novel research questions using comprehensive registry data in a large, national Finnish birth cohort on the relationship between use of selective serotonin reuptake inhibitor (SSRI) medications during pregnancy and psychiatric disorders from birth to age 21. The safety of SSRIs during pregnancy is a question of clear importance to patients and clinicians. The prevalence of major depression in pregnancy is 5-10%, and as many as 20% of pregnant women experience depressive symptoms. Gestational SSRI use has also been increasing in other countries, including Finland, where the proportion of pregnant women purchasing antidepressants increased significantly from 1996 to 2010. Given the particularly high prevalence of depression in women and the increasing use of SSRIs, more research is needed to investigate potential short- and long-term harms to the fetus. Only recently have studies attempted to investigate this issue in population-based birth cohorts. We have previously investigated relationships between maternal SSRIs and several neuropsychiatric outcomes, including depression, anxiety, autism spectrum disorder, attention deficit hyperactivity disorder, and speech/language disorders until 14 years’ age. We shall extend the follow up until age 21, which will permit us to examine the risk trajectory of the previously observed increased risk of depression following maternal SSRI exposure and will markedly increase the sample size. The additional 7 years of follow-up, through adolescence and early adulthood, will permit us to examine whether the sharp rise in risk of the previously observed offspring depression continues into these age groups. This will also allow us to augment the sample of maternal SSRI-exposed subjects, for a total of estimated ~29,000 children born from 1996-2016.
• Study status:
  Planned

Research institutions and networks

Institutions

University of Turku

Columbia University, NY New York

Study timelines

Date when funding contract was signed

Actual: 31/10/2018

Study start date

Planned: 01/06/2020

Data analysis start date

Planned: 30/09/2020

Date of interim report, if expected

Planned: 31/03/2021

Date of final study report

Planned: 31/10/2022

Sources of funding

Other

More details on funding

National Institute of Mental Health, U.S.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable