Chronic Kidney Disease Antidepressant Sertraline Trial

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Texas Southwestern Medical Center
• Treatments: Antidepressive Agents; Sertraline

Criteria

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 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