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Trial record 69 of 89 for:    DESVENLAFAXINE

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

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ClinicalTrials.gov Identifier: NCT02320240
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : March 14, 2016
Sponsor:
Collaborators:
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Canadian Network for Observational Drug Effect Studies, CNODES

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.

Condition or disease Intervention/treatment
Depression Acute Kidney Injury Drug: Duloxetine Drug: Venlafaxine Drug: Desvenlafaxine Drug: Citalopram Drug: Escitalopram Drug: Fluoxetine Drug: Fluvoxamine Drug: Paroxetine Drug: Sertraline

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.

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Study Type : Observational
Actual Enrollment : 3255526 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320240


Locations
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Canada, Quebec
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Canadian Network for Observational Drug Effect Studies, CNODES
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Pierre Ernst, MD, MSc Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University

Additional Information:
Publications of Results:
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Responsible Party: Canadian Network for Observational Drug Effect Studies, CNODES
ClinicalTrials.gov Identifier: NCT02320240     History of Changes
Other Study ID Numbers: Q12-08
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Keywords provided by Canadian Network for Observational Drug Effect Studies, CNODES:
antidepressants
acute kidney injury
SNRI
renal failure
duloxetine
CNODES
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Norepinephrine
Duloxetine Hydrochloride
Dexetimide
Fluvoxamine
Citalopram
Fluoxetine
Paroxetine
Venlafaxine Hydrochloride
Sertraline
Serotonin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents