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ACTIVE NOT RECRUITING
NCT07387120

Sertraline and the Risk of Serious Adverse Events

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

Summary

The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 50 mg/day of Sertraline, a higher dose, compared to 25 mg/day, a lower dose, in adults aged 65+ with low kidney function. The primary question is whether initiating a new outpatient prescription of a higher dose of Sertraline (50mg/day) compared to a lower dose (25 mg/day) in older adults with low kidney function (an eGFR \<45 mL/min per 1.73 m2, but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 30-day risk. The outcome measured will be a composite of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.

Official title: Sertraline Dose and the Risk of Serious Adverse Events in Older Adults With Low Kidney Function: A Population-Based Cohort Study Research Protocol

Key Details

Gender

All

Age Range

66 Years - Any

Study Type

OBSERVATIONAL

Enrollment

6893

Start Date

2008-01-01

Completion Date

2027-12-31

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DRUG

Sertraline 50 mg

The primary exposure of interest will be oral Sertraline at a dose of 50 mg/day.

DRUG

Sertraline 25 mg

The primary exposure of interest will be oral Sertraline at a dose of 25 mg/day.

Locations (1)

London Health Sciences Centre Research Institute

London, Ontario, Canada