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Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

This study is currently recruiting participants.
Verified March 2013 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00946998
First received: July 23, 2009
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Chronic Kidney Disease
Depression
 Drug: Sertraline
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Improvement in depression symptom severity as measured by the QIDS-C-16 score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
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: Arm 2
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts
Contact: Susan Hedayati, MD MHS (214) 857-2214 susan.hedayati@va.gov
Contact: Mieshia T Beamon (214) 857-1906 Mieshia.Beamon@va.gov

Locations
United States, Texas
VA North Texas Health Care System, Dallas Recruiting
Dallas, Texas, United States, 75216
Contact: Debbie A Lindquist, BS     214-857-0238     debbie.lindquist@va.gov    
Contact: Julie R Propes     (214) 857-0240     Julie.Propes@va.gov    
Principal Investigator: Susan Hedayati, MD MHS            
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Kyle West, MA     214-645-8290     Kyle.West@UTSouthwestern.edu    
Sponsors and Collaborators
Department of Veterans Affairs
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Susan Hedayati, MD MHS VA North Texas Health Care System, Dallas
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00946998     History of Changes
Other Study ID Numbers: CLIN-008-09S, 1I01CX000217-01, 1R01DK085512-01A1
Study First Received: July 23, 2009
Last Updated: March 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Chronic Kidney Disease
Depression
Antidepressants
 randomized controlled trial
treatment
Sertraline

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Depression
Depressive Disorder
Kidney Diseases
Kidney Failure, Chronic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency
Antidepressive Agents
 Sertraline
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013