Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

Study ID
STU 012011-196

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • UT Southwestern University Hospital—St. Paul
  • Parkland Health & Hospital System

Contact
Kyle West
214-645-8294
kyle.west@utsouthwestern.edu

Principal Investigator
S Hedayati

Summary

after signing informed consent, subjects will be administered the Mini international neuropsychiatric interview (Mini) to determine if a current MDe is present. if eligible, the subject will be invited to enter a single-blinded one-week placebo run-in period (Period B) to monitor compliance prior to randomization. Those who are non-compliant, defined as the ingestion of [Less Than]65% or [Greater Than]120% of study drug, will be excluded. The subject will then enter the double-blind phase (Period C) and be randomized to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. 25 mg minimal dose of sertraline is allowed (instead of 50 mg) for those patients who may not tolerate the 50 mg dose due to any inadvertent side effects. Subjects will be seen as outpatients every 2 weeks for 6 weeks for titration of drug based on response and tolerability of side effects. The subject will be maintained on a constant drug dose after the 6 week visit and reassessed for depressive symptoms during visits at weeks 9 and 12. at 12 weeks, tapering of drug at the rate of 50 mg/week will commence until drug is discontinued, which will take a maximum of 4 weeks (Period D). The subject will return for a final visit 2 weeks after discontinuation of study drug and be reassessed to see if further clinical follow-up is required for depression.

Participant Eligibility

1) Male or female adults aged 21 years and older. There will be no upper age limit.
2) Presence of stages 3, 4 or 5 CKD based on the National Kidney Foundation definition as an estimated glomerular filtration rate (GFR) of <60 mL/min/1.73 m2 for a period of at least 3 months (5). Stage 5 patients are eligible only if not initiated on dialysis or recipient of kidney transplantation. The estimated GFR will be determined using the four-variable Modification of Diet for Renal Disease Study formula (82).
3) Presence of a current MDE based on MINI DSM IV-based criteria (72)
4) Quick Inventory of Depressive SymptomatologyxSelf-report (QID-SR-16) score of >=11 at enrollment and >=11 on QIDS-C-16 (QIDS-Clinician rated) at randomization.
5) Able to understand and sign informed consent after the study has been fully expla