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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

July 23, 2009
July 27, 2009
January 12, 2018
January 30, 2018
March 9, 2018
February 8, 2010
November 23, 2016   (Final data collection date for primary outcome measure)
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.
Improvement in depression symptom severity as measured by the QIDS-C-16 score. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00946998 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • Serious Adverse Events During the 12 Week Study Duration. [ Time Frame: during 12 week study duration ]
    death, dialysis initiation, hospitalizations, or bleeding requiring transfusion
  • 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: 12 weeks ]
  • Improvement in overall function as assessed by the Work and Social Adjustment Scale [ Time Frame: 12 weeks ]
  • Improvement in quality of life [ Time Frame: 12 weeks ]
  • Serious adverse events [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Chronic Kidney Disease Antidepressant Sertraline Trial
Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Depression
  • 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
  • Drug: placebo
    Placebo tablet will be identical and matched to sertraline tablet.
  • Active Comparator: Sertraline
    Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
    Intervention: Drug: Sertraline
  • Placebo Comparator: Placebo
    Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
200
November 2017
November 23, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00946998
CLIN-008-09S
1I01CX000217-01 ( U.S. NIH Grant/Contract )
1R01DK085512-01A1 ( U.S. NIH Grant/Contract )
Yes
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
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
  • University of Texas Southwestern Medical Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Susan S Hedayati, MD MHS University of Texas Southwestern Medical Center
VA Office of Research and Development
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP