Kidney Week

Abstract: FR-PO1066

CKD Antidepressant Sertraline Trial (CAST)

Session Information

• Late-Breaking Clinical Trial Posters
  November 03, 2017 | Location: Hall H, Morial Convention Center
  Abstract Time: 10:00 AM - 10:00 AM

Category: Chronic Kidney Disease (Non-Dialysis)

• 305 CKD: Clinical Trials and Tubulointerstitial Disorders

Authors

• Hedayati, Susan, University of Texas Southwestern, Dallas, Texas, United States

Susan Hedayati,

• Gregg, Lucile Parker, University of Texas Southwestern, Dallas, Texas, United States

Lucile Parker Gregg,

• Carmody, Thomas, UT Southwestern Medical Center, Dallas, Texas, United States

Thomas Carmody,

• Jain, Nishank, Little Rock VA Hospital, Little Rock, Arkansas, United States

Nishank Jain,

• Toups, Marisa S, UT Dell Medical School, Austin, Texas, United States

Marisa S Toups,

• Rush, Augustus J, Duke-NUS, Santa Fe, New Mexico, United States

Augustus J Rush,

• Toto, Robert D., University of Texas Southwestern Medical Center, Dallas, Texas, United States

Robert D. Toto,

• Trivedi, Madhukar, UT Southwestern Medical Center, Dallas, Texas, United States

Madhukar Trivedi,

Background

Major Depressive Disorder (MDD) is prevalent in CKD patients and associated with morbidity and mortality. Efficacy and safety of selective serotonin reuptake inhibitors in these patients are unknown. CAST (Clinicaltrials.gov NCT00946998) is the first well-powered, randomized, double-blinded, placebo-controlled trial in nondialysis stages 3-5 CKD patients to determine if treatment with sertraline improves depression and quality of life (QOL) and is safe and tolerable.

Methods

After a 1-week placebo run-in, 201 patients with MDD, established by the Mini Neuropsychiatric Interview, were randomized to 12 weeks of 50 mg/day of sertraline or matching placebo, escalated to a maximum tolerated dose of 200 mg/day. The primary prespecified outcome was improvement in depression severity from baseline by the Quick Inventory of Depression Symptomatology Clinician-Rated scale (QIDS). Secondary outcomes were safety and improvement in QOL.

Results

Intention-to-treat analysis included 193 patients (CKD stages 3a, 3b, 4, and 5: 11%, 36%, 36%, 17%) who received at least one post-randomization outcome assessment. The baseline QIDS score was 14.0 ±2.4 in the sertraline (N=97) and 14.1 ±2.4 in the placebo (N=96) group. The median participation time was 12.0 weeks and median achieved dose 150 mg/day, not different between groups. The QIDS score changed by -4.1, 95% CI (-5.1, -3.1) in the sertraline and -4.2 (-5.0, -3.5) in the placebo group; between-group difference, -0.1 (-1.3 to 1.1), P=.82 (Figure). Serious adverse events and changes in QOL were comparable between groups. Nausea or vomiting (23 vs. 10%, P=.03) and diarrhea (13 vs. 3%, P=.02) occurred more frequently in the sertraline vs. placebo arm.

Conclusion

In nondialysis CKD patients, treatment with sertraline did not improve depression or QOL and increased adverse events. These data do not support the use of sertraline to treat depression in CKD, which can have significant impact on clinical practice. (Funding: 1R01DK085512)

Funding

• NIDDK Support