DepressionSNRI-AKINCT02320240
Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
An observational study of Depression and Acute Kidney Injury, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Depression, Acute Kidney Injury
- What is being tested?
- Duloxetine, Venlafaxine and Desvenlafaxine
- How many people
- 3,255,526 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, H3T1E2
About this study
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.
Read the 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
- Depression, Acute Kidney Injury
- Being tested
- Duloxetine, Venlafaxine, Desvenlafaxine, Citalopram, Escitalopram
- Keywords
- antidepressants, acute kidney injury, SNRI, renal failure, duloxetine, CNODES
- Medical subject headings
- Depression, Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
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.
VenlafaxineDrug
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.
DesvenlafaxineDrug
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.
CitalopramDrug
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.
EscitalopramDrug
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.
FluoxetineDrug
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.
FluvoxamineDrug
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.
ParoxetineDrug
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.
SertralineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Duloxetine; Drug: Venlafaxine; Drug: Desvenlafaxine | |
| 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. Receives: Drug: Citalopram; Drug: Escitalopram; Drug: Fluoxetine; Drug: Fluvoxamine; Drug: Paroxetine; Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury (AKI)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,255,526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Pierre Ernst, MD, MSc, Principal investigator, Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320240
- Sponsor's protocol ID
- Q12-08
- Acronym
- SNRI-AKI
- Status last verified
- Mar 2016
- First submitted
- 16 Dec 2014
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Renoux C, Lix LM, Patenaude V, Bresee LC, Paterson JM, Lafrance JP, Tamim H, Mahmud SM, Alsabbagh MW, Hemmelgarn B, Dormuth CR, Ernst P; Canadian Network of Observational Drug Effect Studies (CNODES) Investigators. Serotonin-Norepinephrine Reuptake Inhibitors and the Risk of AKI: A Cohort Study of Eight Administrative Databases and Meta-Analysis. Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1716-22. doi: 10.2215/CJN.11271114. Epub 2015 Jul 31.
PubMed 26231193
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02320240
- Acronym / sponsor ID
- SNRI-AKI / Q12-08
- Conditions
- Depression, Acute Kidney Injury
- Keywords
- antidepressants, acute kidney injury, SNRI, renal failure, duloxetine, CNODES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,255,526 participants (actual)
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODESUniversity, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNRI Exposure Group | – | Drug: Duloxetine, Drug: Venlafaxine, Drug: DesvenlafaxinePatients 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 | – | Drug: Citalopram, Drug: Escitalopram, Drug: Fluoxetine, Drug: Fluvoxamine, Drug: Paroxetine, Drug: SertralinePatients 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineCurrent 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 | SNRI Exposure Group |
| VenlafaxineCurrent 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 | SNRI Exposure Group |
| DesvenlafaxineCurrent exposure to Desvenlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date. | Drug | SNRI Exposure Group |
| CitalopramCurrent 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 | SSRI Exposure Group |
| EscitalopramCurrent 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 | SSRI Exposure Group |
| FluoxetineCurrent 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 | SSRI Exposure Group |
| FluvoxamineCurrent 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 | SSRI Exposure Group |
| ParoxetineCurrent 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 | SSRI Exposure Group |
| SertralineCurrent exposure to Sertraline will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date. | Drug | SSRI Exposure Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Results publication: PubMed 26231193Renoux C, Lix LM, Patenaude V, Bresee LC, Paterson JM, Lafrance JP, Tamim H, Mahmud SM, Alsabbagh MW, Hemmelgarn B, Dormuth CR, Ernst P; Canadian Network of Observational Drug Effect Studies (CNODES) Investigators. Serotonin-Norepinephrine Reuptake Inhibitors and the Risk of AKI: A Cohort Study of Eight Administrative Databases and Meta-Analysis. Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1716-22. doi: 10.2215/CJN.11271114. Epub 2015 Jul 31.
- This organization's website describing general functions, other CNODES projects, and investigator profiles.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Ernst, MD, MSc principal investigator
Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Acute Kidney Injury, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (AKI) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.