---
title: Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
nct_id: NCT02320240
overall_status: COMPLETED
sponsor: Canadian Network for Observational Drug Effect Studies, CNODES
study_type: OBSERVATIONAL
primary_condition: Depression
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02320240.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02320240"
ct_last_update_post_date: 2016-03-14
last_seen_at: "2026-05-12T06:50:15.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

**NCT ID:** [NCT02320240](https://clinicaltrials.gov/study/NCT02320240)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 3255526
- **Lead Sponsor:** Canadian Network for Observational Drug Effect Studies, CNODES
- **Collaborators:** Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- **Conditions:** Depression, Acute Kidney Injury
- **Start Date:** 2013-06
- **Completion Date:** 2014-12
- **CT.gov Last Update:** 2016-03-14

## Brief 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.

## Eligibility

- **Minimum age:** 12 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **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.

## Interventions

- **Duloxetine** (DRUG) — 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.
- **Venlafaxine** (DRUG) — 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.
- **Desvenlafaxine** (DRUG) — 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.
- **Citalopram** (DRUG) — 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.
- **Escitalopram** (DRUG) — 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.
- **Fluoxetine** (DRUG) — 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.
- **Fluvoxamine** (DRUG) — 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.
- **Paroxetine** (DRUG) — 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.
- **Sertraline** (DRUG) — 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.

## Primary Outcomes

- **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.

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.lady davis institute for medical research, jewish general hospital|montreal|quebec|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02320240.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02320240*  
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