SSRIs during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23798
• EU PAS number:
  EUPAS18909
• Study ID:
  23798
• Official title and acronym:
  SSRIs during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Perform a systematic review of observational studies assessing the risk of autism spectrum disorder and attention deficit hyperactivity disorder associated with maternal selective serotonin re-uptake inhibitor (SSRI) exposure during pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 04/07/2016

Actual: 04/07/2016

Study start date

Planned: 18/07/2016

Actual: 18/07/2016

Data analysis start date

Planned: 25/07/2016

Actual: 01/08/2016

Date of final study report

Planned: 19/06/2017

Actual: 15/01/2018

Sources of funding

EMA

Study protocol

Initial protocol

EUPAS18909.protocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable