Open Access Study protocol

Infant and childhood neurodevelopmental outcomes following prenatal exposure to selective serotonin reuptake inhibitors: overview and design of a Finnish Register-Based Study (FinESSI)

Heli Malm123*, Miia Artama34, Alan S Brown56, Mika Gissler347, David Gyllenberg38, Susanna Hinkka-Yli-Salomäki3, Ian McKeague9 and Andre Sourander35

Author Affiliations

1 Teratology Information, HUSLAB and Helsinki University Central Hospital, Tukholmankatu 17, P.O. BOX 790, 00029 HUS, Helsinki, Finland

2 Department of Clinical Pharmacology, Helsinki University and Helsinki University Central Hospital, Helsinki, Finland

3 Department of Child Psychiatry, University of Turku, Turku, Finland

4 National Institute for Health and Welfare, Helsinki, Finland

5 Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, NY, USA

6 Department of Epidemiology, Columbia University, Mailman School of Public Health, New York, NY, USA

7 Nordic School of Public Health, Gothenburg, Sweden

8 Department of Child Psychiatry, University of Helsinki, Helsinki, Finland

9 Mailman School of Public Health, Department of Biostatistics, Columbia University College of Physicians and Surgeons, New York, NY, USA

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BMC Psychiatry 2012, 12:217  doi:10.1186/1471-244X-12-217

Published: 4 December 2012



Experimental animal studies and one population-based study have suggested an increased risk for adverse neurodevelopmental outcome after prenatal exposure to SSRIs. We describe the methods and design of a population-based study examining the association between prenatal SSRI exposure and neurodevelopment until age 14.

Methods and design

This is a cohort study of national registers in Finland: the Medical Birth Register, the Register of Congenital Malformations, the Hospital Discharge Register including inpatient and outpatient data, the Drug Reimbursement Register, and the Population Register. The total study population includes 845,345 women and their live-born, singleton offspring aged 14 or younger and born during Jan 1st 1996-Dec 31st 2010. We will compare the prevalence of psychiatric and neurodevelopmental outcomes in offspring exposed prenatally to SSRIs to offspring exposed to prenatal depression and unexposed to SSRIs. Associations between exposure and outcome are assessed by statistical methods including specific modeling to account for correlated outcomes within families and differences in duration of follow-up between the exposure groups. Descriptive results. Of all pregnant women with pregnancy ending in delivery (n = 859,359), 1.9% used SSRIs. The prevalence of diagnosed depression and depression-related psychiatric disorders within one year before or during pregnancy was 1.7%. The cumulative incidence of registered psychiatric or neurodevelopmental disorders was 6.9% in 2010 among all offspring born during the study period (age range 0–14 years).


The study has the potential for significant public health importance in providing information on prenatal exposure to SSRIs and long-term neurodevelopment.

SSRI; Pregnancy; Neurodevelopment