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

Study identification

• EU PAS number:
  EUPAS10694
• Study ID:
  10695
• Official title and acronym:
  Infant and childhood neurodevelopmental outcomes following prenatal exposure to selective serotonin reuptake inhibitors: overview and design of a Finnish Register-Based Study (FinESSI)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  This is a cohort study of national registers in Finland: the Medical Birth Register, 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 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. The study has the potential for significant public health importance in providing information on prenatal exposure to SSRIs and long-term neurodevelopment.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Turku

Department Child Psychiatry

Turku University, Child psychitary Turku, Finland, Columbia University NY, U.S.

Study timelines

Date when funding contract was signed

Actual:31/08/2010

Study start date

Actual:15/09/2010

Data analysis start date

Actual:03/01/2011

Date of final study report

Planned:31/12/2015

Sources of funding

Other

More details on funding

NIMH

Regulatory

• Was the study required by a regulatory body?:
  No