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Antidepressant doses under scrutiny for kidney patients

NCT ID NCT07531173

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study examined whether starting a higher dose of two common antidepressants (venlafaxine and duloxetine) increases the risk of emergency visits, hospital stays, or death within 30 days in older adults with chronic kidney disease. Researchers analyzed health records from over 8,600 people aged 66 and older with low kidney function. The goal was to gather safety information, not to test a new treatment.

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

8,688 people

The number who actually took part.

Started

Sep 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 of oral venlafaxine or duloxetine between 2008 and 2025 in Ontario.

Ages

66 years and older

Sex

Anyone

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: * The cohort will include all older adults (≥66 years) with an eGFR \<45 mL/min per 1.73 m2 (not receiving dialysis or having a history of kidney transplantation) who received a new outpatient prescription for oral venlafaxine or duloxetine between January 1, 2008, and December 1, 2025. The age criterion is set to guarantee that individuals in this population have had at least one year of prior 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: * 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), or non-Alberta residents (for Alberta 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 more than one study drug prescription on the index date, as this complicates the ability to ascertain the prescribed dose accurately. * Evidence of clinically non-meaningful venlafaxine or duloxetine doses (doses that are either too low or too high). The recommended dose range for venlafaxine is 37.5 to 150 mg per day, and for duloxetine is 30 to 120 mg per day. * 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. * Individuals with unstable baseline kidney function: If the most recent serum creatinine test prior to the index date was an inpatient test \[ER or hospitalization\], 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 \[ER or hospitalization\], and while there is at least 'outpatient' serum creatinine test in the year before, the most recent outpatient test prior to 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 outpatient serum creatinine measurements in the province, conducted on a single occasion, indicate stable values. * The investigators restrict to the first prescription in individuals with more than one eligible prescription. The date of this prescription will be the index date (the date from which outcomes start being assessed).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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