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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Analysis of discrepancies in results between different databases
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03A) ANTIEPILEPTICS

  ANTIEPILEPTICS
• Medical condition to be studied:
  Suicidal behaviour

  Suicidal ideation

  Completed suicide

  Suicide attempt

Population studied

• Short description of the study population:
  Patients who have received a first prescription to at least one Antiepileptic drugs (AED) at 1-Jul-1996 or later in the UK or Denmark, age of 15 years and older at the index date, a registration history of at least 6 months prior to the index date (first date of AED prescription) and fulfilling research data criteria in General Practice Research Database (GPRD).
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  55700000

Study design details

• Main study objective:
  To assess the association between the use of antiepileptics and the risk of suicidality with different study designs across different primary care databases and to compare the results between databases, across designs to evaluate the impact of design/database/population differences on the outcome of the studied association.
• Data analysis plan:
  Descriptive studies to compare the six European databases. We will estimate point and period prevalence overall and by AEDs for the study period between 1-Jan-2000 and 31-Dec-2009. Analytical studies to evaluate a possible association between anti-epileptic drugs and suicidalityWe will estimate risks of suicidality for all AEDs and by individual AEDs prescribed in UK and Denmark. We will apply two different study design: cohort study, and case-crossover studies. For the cohort study we will apply Cox regression analyses with the following potential confounding factors: gender, age, marital status, socio-economic status, BMI, smoking status, alcohol abuse, drug and medication abuse, number of different drugs prescribed in the six months prior to index date, a number of comorbidities associated with a higher risk for suicidality and calendar period. Exposure to AEDs and anti-depressives will be handled as time varying variables.

Documents

Study results

Abstract Schuerch et al (2016)

Study publications

Schuerch M, Gasse C, Robinson NJ, Alvarez Y, Walls R, Mors O, Christensen J, He…