Sertraline and the Risk of Serious Adverse Events (NCT07387120) | Clinical Trial Compass
CompletedNot Applicable
Sertraline and the Risk of Serious Adverse Events
Canada6,893 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range
66 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine) 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A composite outcome of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.
Timeframe: Older adults exposed to high-dose (50mg/day) vs low-dose (25 mg/day) Sertraline between Jan 1, 2008, and Jan 1,2025 will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date
Trial details
NCT IDNCT07387120
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
. 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.