Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury (SNRI-AKI)

March 11, 2016 updated by: Canadian Network for Observational Drug Effect Studies, CNODES
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3255526

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T1E2
        • Lady Davis Institute for Medical Research, Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The cohort will be formed of all patients in the databases aged 12 or older (or 65 or older in some of the databases) with a first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010. The databases to be included are eight administrative databases from Canada (Alberta, Manitoba, Nova Scotia, Ontario, Quebec, and Saskatchewan), the United States (US MarketScan), and the United Kingdom (CPRD).

Description

Inclusion Criteria:

  • A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010.

Exclusion Criteria:

  • They were <12 years old at the time of cohort entry.
  • They had less than 1 year of information in the database prior to the date of cohort entry.
  • They had a prescription of an SNRI or SSRI in the year before the date of cohort entry.
  • They had a prescription for both an SNRI and an SSRI on the day of cohort entry.
  • They had a history of chronic kidney disease (including kidney transplantation and dialysis) or AKI in the year preceding cohort entry.
  • The subject was previously included in the cohort.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SNRI Exposure Group
Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.
Drug: Duloxetine
Current exposure to Duloxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
Drug: Venlafaxine
Current exposure to Venlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
Drug: Desvenlafaxine
Current exposure to Desvenlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
SSRI Exposure Group
Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.
Drug: Citalopram
Current exposure to Citalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
Drug: Escitalopram
Current exposure to Escitalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
Drug: Fluoxetine
Current exposure to Fluoxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
Drug: Fluvoxamine
Current exposure to Fluvoxamine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
Drug: Paroxetine
Current exposure to Paroxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
Drug: Sertraline
Current exposure to Sertraline will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Kidney Injury (AKI)
Time Frame: 2 years
AKI will be defined as patients hospitalized with one of the following diagnosis codes for AKI in any of the listed diagnoses: ICD-9-CM codes 584, 584.5, 584.6, 584.7, 584.8, or 584.9; ICD-10 N17, N17.0, N17.1, N17.2, N17.8, or N17.9.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Network for Observational Drug Effect Studies, CNODES

Collaborators

Canadian Institutes of Health Research (CIHR)
Drug Safety and Effectiveness Network, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 19, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q12-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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