Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2012

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
• Placebo Comparator: 2
  • Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode

Primary Measures

• Improvement in depression symptom severity as measured by the QIDS-C-16 score.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Improvement in overall function as assessed by the Work and Social Adjustment Scale
  • Time Frame: 12 weeks
    Safety Issue?: No
• Improvement in quality of life
  • Time Frame: 12 weeks
    Safety Issue?: No
• Serious adverse events
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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-SR-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. Acute kidney injury superimposed on CKD.
• 4. Kidney transplant recipient.
• 5. Initiated on maintenance dialysis or anticipated need for dialysis within 3 months.
• 6. Significant hepatic dysfunction or liver enzyme abnormalities.
• 7. Terminal chronic obstructive pulmonary disease or cancer.
• 8. Recent history of active bleeding or current use of warfarin.
• 9. Current use of class I anti-arrhythmic medications.
• 10. Use of reserpine, guanethidine, or methyldopa; neuroleptics or anti-convulsants (excluding gabapentin).
• 11. Ongoing use of anti-depressants or benzodiazepines.
• 12. Past treatment failure on sertraline.
• 13. Initiation of psychotherapy in the 3 months prior to study entry.
• 14. Alcohol or substance abuse or dependence in the past 6 months.
• 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, or women of childbearing potential not using adequate contraception.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Department of Veterans Affairs

Overall Clinical Trial Officials and Contacts

Susan Hedayati, MD MHS Principal Investigator VA North Texas Health Care System, Dallas  

Overall Contact: Susan Hedayati, MD MHS (214) 857-2214 susan.hedayati@va.gov

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00946998

Study ID Number: CLIN-008-09S

ClinicalTrials.gov Identifier: NCT00946998

Health Authority: United States: Federal Government