Last updated: 11/03/2018 18:30:25

WEUKBRE5557: IMI PROTECT(Work Package 2): Antiepileptics & suicide

GSK study ID
115737
Clinicaltrials.gov ID
NCT01607333
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: WEUKBRE5557: IMI PROTECT (Work Package 2): Use of antiepileptics and risk of suicidality
Trial 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) Workpackage 2 and Workgroup 1. 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 five key adverse events (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of the association under investigation.
In the present project, investigators use Columbia Classification Algorithm of suicide assessment (C-CASA) definitions as a basis to specify the operational definitions of the different aspects of suicidality. The focus of the main analyses is on attempted suicide including completed suicide. This is due to statistical power issues. However, investigators will apply two additional outcome definitions in sensitivity analyses: 1) completed suicide only and 2) completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation plus indeterminate or potentially suicidal events. Investigators will not include terms which clearly indicate an accidental event, or self-injurious behavior without a suicidal intent. These definitions are listed in the statistical analysis plan together with lists of terms from the dictionaries used in the different databases.
The objectives of this study are to 1) Compare the study results which are based on two data sources (he UK General Practice Research Database (GPRD) and Danish registries) and different designs and evaluate the impact of design and population differences on the outcome of the study results (the UK database ‘The Health Improvement Network’ (THIN) may be included in these analyses as well); 2) Evaluate the strengths and weaknesses of the two data sources to study a possible association of antiepileptic drug (AED) use and suicidality, in particular the specific outcomes of death from suicide, hospitalization due to suicide attempt, and reports of the aspects of suicidality by the patients; 3) Estimate risks of completed suicide, completed suicide and attempted suicide, and completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation plus indeterminate or potentially suicidal events overall for all AEDs and by individual AEDs prescribed in UK and Denmark; and 4) Describe the patterns of AED prescribing in six European databases (GPRD and THIN, UK; Danish registries; Mondriaan, Netherlands; Bavaria, Germany; Base de Datos para la Investigación Farmacoepidemiologica en Atencion Primaria (BIFAP), Spain).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Suicide attempt including completed suicide identified in GPRD from Read codes and cause of death; and ICD-9 codes and cause of death from Death Registry in Danish database

Timeframe: Up to 13 and a half years following drug exposure

Secondary outcomes:

Completed suicide only identified in GPRD from Read codes and cause of death; and ICD-9 codes and cause of death from Death Registry in Danish database only

Timeframe: Up to 13 and a half years following drug exposure

Completed suicide, suicide attempt, and including preparatory acts toward imminent suicidal behavior, suicidal ideation plus indeterminate or potentially suicidal events (wide definition) in GPRD only

Timeframe: Up to 13 and a half years following drug exposure

Interventions:
  • Drug: Lamotrigine use
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    December 2011 to July 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Inclusion Criteria for the descriptive studies to compare the six European databases:
    • patients with at least one prescription to an AED between January 1, 2000 and December 31, 2009
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria for the descriptive studies to compare the six European databases:
    • patients with at least one prescription to an AED between January 1, 2000 and December 31, 2009
    • patients who fulfill the quality criteria of the respective database Inclusion Criteria for the additional descriptive studies comparing the study populations from GPRD and Danish data sources and cohort study:
    • patients who have received a first prescription to at least one AED at July 1, 1996 or later in the UK or Denmark
    • patients who are an age of 15 years and older at the index date
    • patients who have a registration history of at least 6 months prior to the index date (first date of AED prescription)
    • patients who have fulfilled research data criteria in GPRD Exclusion Criteria for the descriptive studies to compare the six European databases and the nested case-control study:
    • patients without a prescription to an AED between January 1, 2000 and December 31, 2009
    • patients who do not fulfill the quality criteria of the respective database Exclusion Criteria for the additional descriptive studies comparing the study populations from GPRD and Danish data sources and cohort study:
    • patients without a first prescription to at least one AED at July 1, 1996 or later in the UK or Denmark
    • patients younger than age of 15 years at the index date
    • patients who do not have a registration history of at least 6 months prior to the index date (first date of AED prescription)
    • patients who have not fulfilled research data criteria in GPRD
    • patients with records of coded suicidality (wide definition, including suicidal ideation) in the six months prior to the index date

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-30-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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