Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish registries with an evaluation of available data from further European data sources.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/13022
• EU PAS number:
  EUPAS2356
• Study ID:
  13022
• Official title and acronym:
  Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish registries with an evaluation of available data from further European data sources.
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Netherlands

  Spain

  United Kingdom
• Study description:
  The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work Package 2 and Working Group 1. The primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on 5 key Drug / adverse events (D-AEs) pairs performed in different databases will be evaluated. The use of antiepileptics associated with the risk of suicidality is one of the key D-Ae pair of interest. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of studying the association under investigation.
• Study status:
  Finalised

Research institutions and networks

Institutions

F. Hoffmann-La Roche

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

European Medicines Agency (EMA)

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Spain

Ludwig-Maximilians-University Munich

Agencia Espanola del Medicamento y Productos Sanitarios (AEMPS) Spain, European Medicines Agency (EMA) United Kingdom, Lægemiddelstyrelsen (Danish Medicines Agency (DKMA) Denmark, Ludwig-Maximilians-Universität-München (LMU MUNCHEN) Germany, F.Hoffmann-La Roche AG Switzerland

Networks

PROTECT

Belgium

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 19/08/2009

Actual: 19/08/2009

Study start date

Planned: 03/10/2011

Actual: 03/10/2011

Date of final study report

Planned: 31/12/2013

Actual: 01/04/2016

Sources of funding

EU institutional research programme

Pharmaceutical company and other private sector 

More details on funding

Amgen, AstraZeneca, Genzyme, GSK, MerckSerono, Novartis, Roche, Pfizer, Innovative Medicines Initiative (IMI)

Study protocol

Initial protocol

PROTECT_WP2 Final Protocol_Suicide_Anticonvulsants_Dec 16 2011_Amend 1 approved 5Oct2012

Updated protocol

PROTECT WP2 Final protocol_AED Suicidality_Amend3_15Feb2013approved

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable