Antidepressants withdrawal syndrome: a pharmacovigilance study in VigiBase®

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case/Non-case study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06A) ANTIDEPRESSANTS

  ANTIDEPRESSANTS
• Medical condition to be studied:
  Antidepressant discontinuation syndrome

  Drug withdrawal syndrome

  Withdrawal syndrome

Population studied

• Short description of the study population:
  We will include all ICSRs registered between January 1, 1988, and December 31, 2020, with age and sex known. All patients aged 6 or older on the date of the reports and treated by an antidepressant among SRI, SNRI, tricyclic or atypical antidepressant (listed in Exposure definition) were included. Patients whose sex and age were unknown were excluded.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  340000

Study design details

• Main study objective:
  Compare the risk of reporting withdrawal syndrome after discontinuation of short half-lives antidepressants and long half-lives antidepressants among Serotonin Reuptake Inhibitors (SRI), Serotonin and Norepinephrine Reuptake inhibitors (SNRI) and atypical antidepressants.
• Outcomes:
  Risk of reporting a withdrawal syndrome
• Data analysis plan:
  Data will be extracted from VigiBase(R) Using a case/non-case design, we will perform a multivariate logistic regression to estimate reporting odds ratios (RORs) with their 95% confidence interval (CI). The reporting odds ratios (ROR) is the exposure odds among reported cases of withdrawal syndrome to the exposure odds among reported non-cases. Sensitivity analyses will be conducted (restricting analyses to physician reports only, to USA reports only, to the last 5 years only).