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Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

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ClinicalTrials.gov Identifier: NCT00946998
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : January 30, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Depression Drug: Sertraline Drug: placebo Phase 3

Detailed Description:
This is a randomized double-blinded placebo-controlled trial of adults with predialysis stages 3-5 Chronic Kidney Disease and Major Depressive Episode. Subjects will be randomized in a double-blind fashion to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. The primary outcome is to investigate if treatment with sertraline, as compared with placebo, results in an improvement in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C-16) score. Secondary outcomes include whether sertraline, as compared with placebo, improves overall function and quality of life and whether it will result in more serious adverse events.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease
Actual Study Start Date : February 8, 2010
Actual Primary Completion Date : November 23, 2016
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sertraline
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
 Drug: Sertraline
Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d
Placebo Comparator: Placebo
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
 Drug: placebo
Placebo tablet will be identical and matched to sertraline tablet.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score. [ Time Frame: baseline to 12 weeks ]
    The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.


Secondary Outcome Measures :
  1. Response to Treatment Defined as a Decline of 50% in the Baseline QIDS-C-16 Score and Remission of Depression Defined as a QIDS-C-16 Score of 5 [ Time Frame: baseline to 12 weeks ]
    The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.

  2. Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale [ Time Frame: baseline to 12 weeks ]
    Each item is rated on a 0 to 8 Likert scale with 0 indicating no impairment and 8 indicating severe impairment and a total score range of 0 to 40.

  3. Change in Quality of Life From Baseline to Exit in the Kidney Disease Quality of Life -Short Form, Version 1.3, Patient-reported Overall Health. [ Time Frame: baseline to 12 weeks ]
    Raw scores from version 1.3 were transformed to a scale from 0 to 100, in which higher numbers signify more favorable quality of life.

  4. Serious Adverse Events During the 12 Week Study Duration. [ Time Frame: during 12 week study duration ]
    death, dialysis initiation, hospitalizations, or bleeding requiring transfusion


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female adults aged greater than 21 years.
  • Predialysis stages 3, 4 or 5 CKD.
  • Current Major Depressive Episode.
  • QID-C-16 score of 11.
  • Able to understand and sign informed consent.

Exclusion Criteria:

  • No healthcare power of attorney to sign informed consent.
  • Unwilling or unable to participate.
  • Kidney transplant recipient.
  • Initiated on maintenance dialysis
  • Significant hepatic dysfunction or liver enzyme abnormalities 3 times the upper limits of normal.
  • Terminal chronic obstructive pulmonary disease or cancer.
  • Recent history of active bleeding, such as gastrointestinal bleeding requiring hospitalization 3 months prior
  • Current use of class I anti-arrhythmic medications.
  • Use of pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine or methyldopa; tri-cyclic anti-depressants, neuroleptics or anti-convulsants, excluding gabapentin
  • Use of other serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort.
  • Ongoing use of anti-depressants
  • Past treatment failure on Sertraline
  • Initiation of psychotherapy for depression in the 3 months prior to study entry
  • Alcohol or substance abuse or dependence that requires acute detoxification at study entry
  • Present or past psychosis or Bipolar I or II disorder
  • Dementia or a Mini-Mental State Examination score of <23
  • Suicidal ideation
  • Pregnancy, lactation and women of childbearing potential not using adequate contraception
Contacts and Locations
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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): NCT00946998


Locations
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
VA Office of Research and Development
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Susan S Hedayati, MD MHS University of Texas Southwestern Medical Center
More Information
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Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00946998     History of Changes
Other Study ID Numbers: CLIN-008-09S
1I01CX000217-01 ( U.S. NIH Grant/Contract )
1R01DK085512-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2009    Key Record Dates
Results First Posted: January 30, 2018
Last Update Posted: March 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Chronic Kidney Disease
Depression
Antidepressants
 randomized controlled trial
treatment
Sertraline

Additional relevant MeSH terms:
Depression
Depressive Disorder
Kidney Diseases
Renal Insufficiency, Chronic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency
Antidepressive Agents
 Sertraline
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs