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Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
sertraline
Health Outcome(s)
hospitalized depression
intentional self-harm
Description

This analysis estimated the risk of intentional self-harm and hospitalized depression comparing brand name sertraline to its authorized generic in the Sentinel Distributed Database. This analysis was divided into four reports:

  • Report 1 does not include covariates for socioeconomic status in the propensity score models. 
  • Report 2 includes covariates for socioeconomic status in the propensity score models.
  • Report 3 assesses the risk of hospitalized depression.
  • Report 4 assesses the risk of hospitalized depression and includes covariates for socioeconomic status in the propensity score.

The study period includes data from June 30, 2006 to September 30, 2015. We distributed this request to 17 Data Partners on July 30, 2019. Only the results from four Data Partners whose propensity score models converged are included in these reports. 

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Deliverables (5)
Sentinel Analytic Package: Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis Sentinel Modular Program Report: Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis, Report 1 Sentinel Modular Program Report: Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis, Report 2 Sentinel Modular Program Report: Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis, Report 3 Sentinel Modular Program Report: Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis, Report 4
Additional Details
FDA Center
CDER
Time Period
June 30, 2006 - September 30, 2015
Analysis Type
Retrospective Inferential
Population / Cohort
Individuals 12 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Hospitalized Depression Algorithm Defined in "Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis"
Intentional Self-Harm Algorithm Defined in "Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis"
Intentional Self-Harm and Hospitalized Depression Following Sertraline Use: A Propensity Score Matched Analysis (A Follow-up to a Previous Analysis)
Sentinel Drug Study: Zoloft (Sertraline) & Intentional Self-Harm and Hospitalized Depression