Chronic Kidney Disease Antidepressant Sertraline Trial
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease; Depression
Intervention: Sertraline (Drug); placebo (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Susan Hedayati, MD MHS, Principal Investigator, Affiliation: VA North Texas Health Care System, Dallas
Overall contact:
Susan Hedayati, MD MHS, Phone: (214) 857-2214, Email: susan.hedayati@va.gov
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.
Clinical Details
Official title: Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement in depression symptom severity as measured by the QIDS-C-16 score.
Secondary outcome: 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 5Improvement in overall function as assessed by the Work and Social Adjustment Scale Improvement in quality of life Serious adverse events
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
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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-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. Women of childbearing potential not using adequate contraception.
Locations and Contacts
Susan Hedayati, MD MHS, Phone: (214) 857-2214, Email: susan.hedayati@va.gov
VA North Texas Health Care System, Dallas, Dallas, Texas 75216, United States
Additional Information
Starting date: November 2009
Ending date: October 2012
Last updated: July 24, 2009
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