Chronic Kidney Disease Antidepressant Sertraline Trial

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Parkland Health & Hospital System

Kyle West

Principal Investigator
S Hedayati, M.D.

Official Title

Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease

Brief Overview

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


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.

Participant Eligibility

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

- 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