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Higher antidepressant dose may raise risks for seniors with weak kidneys

NCT ID NCT07387120

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This completed study looked at nearly 7,000 older adults (65+) with low kidney function who started taking the antidepressant sertraline. Researchers compared the safety of a 50 mg daily dose versus a 25 mg daily dose, tracking hospital visits, emergency department visits, or death within 30 days. The goal was to see if the higher dose poses greater risks in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sertraline
What this could lead to
If successful, this could help doctors choose safer antidepressant doses for older adults with kidney problems.
What could go wrong
This is an observational study, not a controlled trial, so it can show links but not prove cause and effect. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

6,893 people

The number who actually took part.

Started

Jan 2008

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults aged 66 years or older with low kidney function (eGFR \<45 mL/min per 1.73 m2 but not receiving dialysis or having a history of kidney transplantation) who have filled a new outpatient prescription for Sertraline with a dose of 25 or 50 mg/day and a day supply of ≥7 days between 2008 and 2024 in Ontario. The study accrual period for Alberta (if needed) will be determined based on data availability.

Ages

66 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Older adult aged 66 years or greater with low kidney function (an eGFR \<45 mL/min per 1.73 m2 ) who have filled a new oral prescription for Sertraline at an outpatient pharmacy under the Ontario Drug Benefit (ODB) program with a dose of 25 or 50 mg/day and a day supply of ≥7 days from January 1, 2008, to January 1, 2025 for Ontario (if needed, dates in Alberta to be finalized based on data availability). The investigators will exclude individuals undergoing dialysis or those who have received a kidney transplant. The age criterion is set to guarantee that individuals in this population had at least one year of prior universal outpatient prescription drug coverage. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once. Exclusion Criteria: 1. 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). 2. Individuals less than 66 years of age on the index date. 3. Those with evidence of any study drug prescription 180 days before the index date (to restrict to new users only). 4. 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. 5. Individuals with more than one study drug prescription on the index date, as this complicates the ability to ascertain the prescribed dose accurately. 6. Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date. 7. 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. 8. Individuals with no serum creatinine lab value in the 0-365 days prior to the index date. 9. Individuals with unstable baseline kidney function: * If the most recent serum creatinine test prior to the index date was an inpatient test \[ER or hospitalization\] (refer to this as test date 1), and there is not at least one 'outpatient' serum creatinine in the year before test date 1, OR * If the most recent prior serum creatinine test prior to the index date was an inpatient test \[ER or hospitalization\] (refer to this as test date 1), and while there is at least 'outpatient' serum creatinine test in the year before (test date 1), the most recent outpatient test prior to (test date 1) differs by an eGFR 10 mL/min/1.73 m2 or more from the value on (test date 1). In Ontario, it has been shown that an outpatient serum creatinine measurement in the province, conducted on a single occasion, usually represents a stable value. 10. Individuals receiving palliative care in the year prior to the index date, as in this setting dosing is less relevant; rather, the focus is comfort care. The investigators will restrict to the first prescription in individuals with more than one eligible prescription. Date of this prescription will be the index date (the date from which the outcomes start being assessed).

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Drug-Related Side Effects and Adverse Reactions

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • London Health Sciences Centre Research Institute

    London, Ontario, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.