CompletedNot Applicable

Citalopram and the Risk of Serious Adverse Events

Canada7,110 participantsStarted 2008-01-01

Plain-language summary

This population-based cohort study aims to evaluate the safety of initiating a new outpatient prescription of citalopram at 20 mg/day (higher dose) compared to 10 mg/day (lower dose) in adults aged 65 years and older with reduced kidney function. The primary research question is whether initiating a higher dose of citalopram (20 mg/day) versus a lower dose (10 mg/day) in older adults with low kidney function (defined as an estimated glomerular filtration rate \[eGFR\] less than 45 mL/min per 1.73 m2, without dialysis or a history of kidney transplantation) is associated with an increased 30-day risk of a composite outcome comprising all-cause hospitalization, all-cause emergency department visits, or all-cause mortality.

Who can participate

Age range66 Years

SexALL

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Exclusion criteria

✕. Individuals with missing administrative database number, missing or invalid age (\<0 or \>105 years), missing or invalid sex, death on or before the index date, non-Ontario resident (for Ontario data).
✕. Individuals less than 66 years of age on the index date.
✕. Those with evidence of any study drug prescription 180 days before the index date (to restrict to new users only).
✕. Individuals with other Selective Serotonin Reuptake Inhibitors (Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline) prescription in the previous 180 days before the index date or on the index date.
✕. Individuals with more than one study drug prescription on the index date, as this complicates the ability to ascertain the prescribed dose accurately.
✕. Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date.
✕. Evidence with hospital discharge or emergency department visit in the two days prior to or on the index date to ensure a new outpatient prescription.
✕. Individuals with no serum creatinine lab value in the 0-365 days prior to the index date.

What they're measuring

A composite outcome of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.

Timeframe: From cohort entry (Day 0) through 30 days post-entry or until first event (hospitalization, ED visit, or death), whichever occurs first.

Trial details

NCT IDNCT07399795

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Chronic Kidney Disease (CKD) trials