Chronic Kidney Disease Antidepressant Sertraline Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Depression

In brief

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.

Key facts

Study ID

NCT00946998

Run by

VA Office of Research and Development

People needed

201

Starts

2010-02-08

Expected to finish

2017-11-01

Last updated by the study team

2018-03-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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