Chronic Kidney Disease Antidepressant Sertraline Trial

Phase 3

Completed

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
Sertraline	Sertraline	Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.	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.

Secondary Outcome Measures

Name	Time	Method
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	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	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.	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.	during 12 week study duration	death, dialysis initiation, hospitalizations, or bleeding requiring transfusion

Locations (2): VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
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Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
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Dallas, Texas, United States