Retinoid-containing medicinal products and Neuropsychiatric disorders: A descriptive analysis of EudraVigilance data

Study identification

• EU PAS number:
  EUPAS36901
• Study ID:
  36902
• Official title and acronym:
  Retinoid-containing medicinal products and Neuropsychiatric disorders: A descriptive analysis of EudraVigilance data
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A cross-sectional descriptive study of case reports of Neuropsychiatric disorders to Retinoid-containing medicinal products was conducted. Case reports were extracted from EudraVigilance, from inception to 19 July 2016 where single or multi-ingredient formulations of Acitretin, Adapalene, Alitretinoin, Bexarotene, Isotretinoin, Tretinoin, Tazarotene were reported as suspect or interacting medicinal products and there was at least one Preferred Term of the Psychiatric disorders SOC.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned:06/09/2016

Actual:06/09/2016

Study start date

Planned:06/09/2016

Actual:06/09/2016

Data analysis start date

Planned:31/08/2016

Actual:31/08/2016

Date of interim report, if expected

Planned:21/09/2016

Actual:21/09/2016

Date of final study report

Planned:23/09/2016

Actual:27/09/2016

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

Other study registration identification numbers and links

EMEA/H/A-31/1446