Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N06A) ANTIDEPRESSANTS

Medical condition to be studied

Depression
Population studied

Short description of the study population

Patients aged 18 or older, resident in metropolitan France, with at least one antidepressants reimbursement in 2013, and without any diagnostic of psychotic disorders, Parkinson's disease, or dementia within the last two years preceding the initiation date, was reported in the study.

Age groups

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)

Special population of interest

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

1000000
Study design details

Main study objective

To estimate the prevalence and incidence of Treatment-Resistant Depression in the French population.

Data analysis plan

A Statistical Analysis Plan (SAP) was developed and validated by the Scientific Committee before the analysis. The statistical analysis was performed using the SAS® software (latest current version), following a detailed statistical analysis plan.The following analyses were performed:• A flow chart depicting the number of patients and sequences of treatment available in the database satisfying the inclusion criteria,• Description of baseline characteristics, comorbidities,• Description of the TDR episode,• Description of the TRD prevalence and incidence in 2012, 2013 and 2014, averaged per year and age- and sex-standardized to the French population,• Description of healthcare resources use during the TRD episode and during the follow-up period.
Documents
Study results
English (5.53 MB - PDF)View document
English (4.64 MB - PDF)View document