Pregnancy outcome following maternal exposure to mirtazapine: a collaborative ENTIS study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9839
• EU PAS number:
  EUPAS2884
• Study ID:
  9839
• Official title and acronym:
  Pregnancy outcome following maternal exposure to mirtazapine: a collaborative ENTIS study
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Finland

  Israel

  Italy

  Netherlands

  Switzerland

  Türkiye

  United Kingdom
• Study description:
  Observational prospective cohort study comparing pregnancy outcomes after exposure to mirtazapine with two matched control groups: exposure to any selective serotonin reuptake inhibitor (SSRI), and general controls without any exposure to medication known to be teratogenic or to any antidepressant.
• Study status:
  Finalised

Research institution and networks

Institutions

Swiss Teratogen Information Service

Multiple centres: 11 centres are involved in the study

Networks

European Network of Teratology Information Services (ENTIS)

Austria

Czechia

Finland

France

Germany

Greece

Italy

Netherlands

Spain

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/08/2012

Actual: 01/08/2012

Study start date

Planned: 03/10/2011

Actual: 03/10/2011

Date of final study report

Planned: 30/04/2015

Actual: 01/06/2015

Sources of funding

Pharmaceutical company and other private sector 

Non for-profit organisation (e.g. charity)

EU institutional research programme

Other

More details on funding

No funding

Regulatory

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