Study identification

PURI

https://redirect.ema.europa.eu/resource/43417

EU PAS number

EUPAS43416

Study ID

43417

Official title and acronym

Exposure to SSRI/SNRI and depression in pregnancy and long-term childhood outcomes: the effect of modifying factors

DARWIN EU® study

No

Study countries

Belgium
Croatia
Denmark
Finland
France
Germany
Ireland
Italy
Malta
Netherlands
Poland
Réunion
Spain
Sweden
Switzerland
Ukraine
United Kingdom

Study description

Approximately, 10-20% of pregnant women suffer from depression and 4-10% use selective serotonin reuptake inhibitor (SSRI) antidepressants at some stage during pregnancy. There is conflicting evidence regarding the risk of congenital anomalies and long-term neurodevelopmental outcomes such as autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) associated with in utero exposure to SSRI and serotonin and norepinephrine reuptake inhibitors (SNRI). Existing studies in the literature often lack the power to assess the effect of time varying confounders such as variation in maternal disease status, breastfeeding, and transient or chronic interactions with other medications on risk of adverse outcomes, and few examine other aspects of neurodevelopment. This study will help create evidence-based clinical guidelines on risks and benefits of antidepressant treatment in pregnancy. The objectives of this study are: 1) to develop algorithms to identify and validate maternal depression, neurodevelopmental outcomes and breastfeeding in healthcare data sources. 2) to describe patterns of SSRI/ SNRI antidepressant use before, during, and after pregnancy and during lactation. This includes describing co-medication patterns, predictors of discontinuation, switching patterns, and trajectories of use over time. 3) to assess the association between in utero exposure to SSRI / SNRIs and neurodevelopmental outcomes. It will examine the potential additional impact of maternal depression, breastfeeding and concomitant exposure to P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) transporter inhibitors/substrates on neurodevelopmental outcomes in children. A second objective is to perform a EUROmediCAT safety study to assess the risk of major congenital anomalies associated with exposure to SSRI / SNRIs in the first trimester of pregnancy, and to evaluate the impact of co-medication with P-gp or BCRP transporter substrates on risk.

Study status

Ongoing
Research institutions and networks

Institutions

Swansea University Medical School
United Kingdom
First published:
01/02/2024
InstitutionEducational InstitutionHospital/Clinic/Other health care facility
Ulster University
United Kingdom (Northern Ireland)
First published:
20/03/2024
InstitutionEducational Institution
NIHW, Finland, CHUT France, University of Ferrara Italy, CNR-IFC, Tuscany Italy, University of Oslo Norway, FISABIO Spain, SAIL Wales UK, EUROmediCAT UK

Contact details

Maria Loane

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme

More details on funding

Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821520.
Study protocol
Initial protocol

Protocol for DP 1.2 v01-10-2021

English (2.1 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable