Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00946998
First received: July 23, 2009
Last updated: September 8, 2014
Last verified: September 2014

July 23, 2009
September 8, 2014
February 2010
October 2015   (final data collection date for primary outcome measure)
Improvement in depression symptom severity as measured by the QIDS-C-16 score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
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: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in overall function as assessed by the Work and Social Adjustment Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Reduction in platelet aggregation and activation in sertraline vs. placebo group, and whether this reduction correlates with higher plasma sertraline levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Determine if sertraline treatment vs. placebo will improve: a. nutritional status; b. adherence to prescribed medications; c. cognitive functioning; and d. markers of inflammation. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Improvement in overall function as assessed by the Work and Social Adjustment Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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: Arm 1
    Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
    Intervention: Drug: Sertraline
  • Placebo Comparator: Arm 2
    Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2016
October 2015   (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
Both
21 Years and older
No
Contact: Susan Hedayati, MD MHS (214) 857-2214 susan.hedayati@va.gov
Contact: Debbie A Lindquist, BS (214) 857-0238 debbie.lindquist@va.gov
United States
 
NCT00946998
CLIN-008-09S, 1I01CX000217-01, 1R01DK085512-01A1
Yes
Department of Veterans Affairs
Department of Veterans Affairs
  • University of Texas Southwestern Medical Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Susan Hedayati, MD MHS VA North Texas Health Care System, Dallas
Department of Veterans Affairs
September 2014

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