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Trials / Completed

CompletedNCT02320240

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Status
Completed
Phase
Study type
Observational
Enrollment
3,255,526 (actual)
Sponsor
Canadian Network for Observational Drug Effect Studies, CNODES · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of depression.

Detailed description

We plan to conduct retrospective population-based cohort studies within eight administrative databases from Canada, the United States, and the United Kingdom. Within each cohort, a nested case-control analysis will be performed to estimate incidence rate ratios (RR) of AKI associated with SNRIs compared to SSRIs using conditional logistic regression, with adjustment for high-dimensional propensity scores at baseline. The overall effect across sites will then be estimated using meta-analytic methods.

Conditions

Interventions

TypeNameDescription
DRUGDuloxetineCurrent exposure to Duloxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
DRUGVenlafaxineCurrent exposure to Venlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
DRUGDesvenlafaxineCurrent exposure to Desvenlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
DRUGCitalopramCurrent exposure to Citalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
DRUGEscitalopramCurrent exposure to Escitalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
DRUGFluoxetineCurrent exposure to Fluoxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
DRUGFluvoxamineCurrent exposure to Fluvoxamine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
DRUGParoxetineCurrent exposure to Paroxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
DRUGSertralineCurrent exposure to Sertraline will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Timeline

Start date
2013-06-01
Primary completion
2014-12-01
Completion
2014-12-01
First posted
2014-12-19
Last updated
2016-03-14

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02320240. Inclusion in this directory is not an endorsement.

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury (NCT02320240) · Clinical Trials Directory