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Antidepressant dose linked to hospital risk in seniors with kidney trouble

NCT ID NCT07527481

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This completed study looked at 5000 older adults (66+) with low kidney function who started taking the antidepressant nortriptyline. Researchers compared those taking more than 10 mg per day to those taking exactly 10 mg per day to see if higher doses increased the chance of an emergency room visit, hospitalization, or death within 30 days. The goal is to find safer prescribing practices for 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
Nortriptyline (a tricyclic antidepressant)
What this could lead to
If successful, this could help doctors prescribe nortriptyline more safely 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

5,000 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 of oral nortriptyline between 2008 and 2025 in Ontario.

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: * 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 nortriptyline 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: 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), or non-Alberta residents (for Alberta 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 more than one study drug prescription on the index date, as this complicates the ability to ascertain the prescribed dose accurately. 5. Evidence of clinically non-meaningful nortriptyline doses (doses that are either too low or too high). The recommended nortriptyline dose range is 10 to 150 mg per day. 6. Evidence of other tricyclic antidepressants in the previous 180 days (including index date). 7. Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date. 8. Evidence of a hospital discharge or emergency department visit in the two days prior to or on the index date to ensure a new outpatient prescription. 9. Individuals with no serum creatinine lab value in the 0-365 days prior to the index date. 10. 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 of 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. 11. 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

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

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