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

Study identification

• 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

Regulatory

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