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Effect of Sertraline on Depressive Symptoms in Patients With Chronic Kidney Disease Without Dialysis Dependence: The CAST Randomized Clinical Trial
Open accessAbstract
Importance: Major depressive disorder (MDD) is prevalent among patients with chronic kidney disease (CKD) and is associated with morbidity and mortality. The efficacy and adverse events of selective serotonin reuptake inhibitors in these patients are unknown. Objective: To determine whether treatment with sertraline improves depressive symptoms in patients with CKD and MDD. Design, Setting, and Participants: The Chronic Kidney Disease Antidepressant Sertraline Trial (CAST) was a randomized, double-blind, placebo-controlled trial involving 201 patients with stage 3, 4, or 5 non-dialysis-dependent CKD, who were enrolled at 3 US medical centers. The Mini Neuropsychiatric Interview was used to establish MDD. The first participant was randomized in March 2010 and the last clinic visit occurred in November 2016. Interventions: After a 1-week placebo run-in, participants were randomized to sertraline (n = 102) for 12 weeks at an initial dose of 50 mg/d (escalated to a maximum dose of 200 mg/d based on tolerability and response) or matching placebo (n = 99). Main Outcomes and Measures: The primary outcome was improvement in depressive symptom severity from baseline to 12 weeks determined by the 16-item Quick Inventory of Depression Symptomatology-Clinician Rated (QIDS-C16) (score range, 0-27; minimal clinically important difference, 2 points). Secondary outcomes included improvement in quality of life (Kidney Disease Quality of Life Survey-Short Form; score range, 0-100; higher scores indicate more favorable quality of life) and adverse events. Results: There were 201 patients (mean [SD] age, 58.2 [13.2] years; 27% female) randomized. The primary analysis included 193 patients who had at least 1 outcome assessment after randomization. The mean (SD) baseline QIDS-C16 score was 14.0 (2.4) in the sertraline group (n = 97) and 14.1 (2.4) in the placebo group (n = 96). The median participation time was 12.0 weeks and the median achieved dose was 150 mg/d, which was not significantly different between the groups. The QIDS-C16 score changed by -4.1 in the sertraline group and by -4.2 in the placebo group (between-group difference, 0.1 [95% CI, -1.1 to 1.3]; P = .82). There was no significant between-group difference in change in patient-reported overall health on the Kidney Disease Quality of Life Survey (median score, 0 in the sertraline group vs 0 in the placebo group; between-group difference, 0 [95% CI, -10.0 to 0]; P = .61). Nausea or vomiting occurred more frequently in the sertraline vs placebo group (22.7% vs 10.4%, respectively; between-group difference, 12.3% [95% CI, 1.9% to 22.6%], P = .03), as well as diarrhea (13.4% vs 3.1%; between-group difference, 10.3% [95% CI, 2.7% to 17.9%], P = .02). Conclusions and Relevance: Among patients with non-dialysis-dependent CKD and MDD, treatment with sertraline compared with placebo for 12 weeks did not significantly improve depressive symptoms. These findings do not support the use of sertraline to treat MDD in patients with non-dialysis-dependent CKD. Trial Registration: clinicaltrials.gov Identifier: NCT00946998.
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“In patients with major depression and non-dialysis-dependent chronic kidney disease, sertraline did not significantly improve depressive symptoms compared with placebo over 12 weeks144.”
From Mechanisms and treatment of late-life depression (2019) · cites this paper as [144]
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“The CKD Antidepressant Sertraline Trial (CAST) evaluated the utility of sertraline for major depressive disorder among patients with non–dialysis-dependent CKD.(75) Although the trial’s primary outcome was a patient’s score on the Quick Inventory of Depression Symptomatology, a PROM not specifically developed in patie…”
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“issues of scale and feasibility were apparent in a much larger randomized placebo‐controlled trial of sertraline in CKD patients.(30) In total 977 of 14 658 CKD patients screened positive for depression.”
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“The poor performance of such interventions may result from a failure to consider the psychological comorbidity of patients.(13,14) Therefore, an appropriate psychological scale is needed to evaluate and understand comorbid psychiatric disorders in MHD patients.”
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“HRQOL and clinical outcomes, enhancing physical functioning by treating diabetes might be crucial in CKD patients, especially in stage 3b [11,33].”
BackgroundVadiei, N., & Bhattacharjee, S. (2018) · International Urology and Nephrology · doi:10.1007/s11255-018-2034-3 · Cited by 6
Wang, E., Zhao, H., Zhao, D., Li, L., & Du, L. (2018) · Frontiers in Genetics · doi:10.3389/fgene.2018.00573 · Cited by 7
“It is reported that up to 20% of CKD cases are caused by genetic forms of renal disease (Almirall, 2016; Hursitoglu, 2016; Mills and He, 2016; Wuttke and Kottgen, 2016; Hedayati et al., 2017; James et al., 2017; Clark et al., 2018).”
BackgroundPost-transplant Psychosocial and Mental Health Care of the Renal Recipient
Dew, M. A., Myaskovsky, L., Steel, J. L., & DiMartini, A. F. (2018) · Springer eBooks · doi:10.1007/978-3-319-94914-7_10 · Cited by 6
Mental health and kidney disease
Chilcot, J., Cogley, C., Carswell, C., Hudson, J. L., Greenwood, S. A., Sharma, S., Bramham, K., Lunn, A. J., & Farrington, K. (2026) · Nature Reviews Nephrology · doi:10.1038/s41581-026-01055-3 · Cited by 5
Эмировна, Г. А., Borodina, L., Pozdnyakov, S. A., & Тимербулатов, И. Ф. (2024) · S S Korsakov Journal of Neurology and Psychiatry · doi:10.17116/jnevro202412406126 · Cited by 5
Post-transplant Psychosocial and Mental Health Care of the Liver Recipient
DiMartini, A. F., Golden, E., Matz, A., Dew, M. A., & Crone, C. C. (2018) · Springer eBooks · doi:10.1007/978-3-319-94914-7_15 · Cited by 6
Zhu, N., Lisinski, A., Lagerberg, T., Johnell, K., Xu, H., Carrero, J. J., & Chang, Z. (2022) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.5515 · Cited by 4
“Randomized clinical trials found that the sertraline group compared to the placebo group did not show a significant improvement in depressive symptoms, but experienced a higher incidence of adverse events.(39,40) Furthermore, long-term use of antidepressants may predispose patients to adverse drug reactions due to the…”
ResultA Practical Primer on How to Detect and Treat Depression in CKD
Gregg, L. P., Goodman, L. C., Carroll, E. Q., & Hedayati, S. S. (2025) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2025.07.020 · Cited by 4
Self-citationQammar, A., Azeem, B., Kumar, S., Kumari, M., Hassan, F., Khurram, L., Kumar, S., Fasih, A., Khan, A., Azeem, M. B., et al. (2024) · Annals of Medicine and Surgery · doi:10.1097/ms9.0000000000002677 · Cited by 6
Depression in patients undergoing hemodialysis: time to treat
Shirazian, S. (2019) · Kidney International · doi:10.1016/j.kint.2019.05.017 · Cited by 4
Treatment of Psychiatric Disorders in Chronic Kidney Disease Patients
Gregg, L. P., & Hedayati, S. S. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-815876-0.00068-1 · Cited by 4
Self-citation(2021) · Wiley eBooks · doi:10.1002/9781119870203.mpg007 · Cited by 4
Safety of Antidepressant Medications to Treat Comorbid Depression in CKD
Hedayati, S. S. (2024) · Clinical Journal of the American Society of Nephrology · doi:10.2215/cjn.0000000000000391 · Cited by 3
Self-citationGregg, L. P., Buren, P. N. V., Ramsey, D. J., Maydon, A., Banerjee, S., Walther, C. P., Virani, S. S., Winkelmayer, W. C., Navaneethan, S. D., & Hedayati, S. S. (2022) · Journal of Investigative Medicine · doi:10.1136/jim-2022-002467 · Cited by 3
Self-citationDepression and Other Psychological Issues in CKD
Jain, N., & Hedayati, S. S. (2023) · Springer eBooks · doi:10.1007/978-3-031-42045-0_25 · Cited by 3
Self-citationDialysis: Medical and Psychological Considerations
Hussain, F., & Zimbrean, P. C. (2018) · Springer eBooks · doi:10.1007/978-3-319-94914-7_7 · Cited by 3
Depression in patients with CKD and ESRD
Quinn, D. K., & Cukor, D. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-817080-9.00007-5 · Cited by 3
Chilcot, J., & Farrington, K. (2019) · Clinical Kidney Journal · doi:10.1093/ckj/sfz160 · Cited by 3
“Furthermore, we highlighted three randomized placebo-controlled trials of SSRIs in individuals with kidney disease [3–5] that failed to show evidence of efficacy but indicated increased risks of adverse events.”
BackgroundPsychological challenges and psychiatric illness in earlier stages of CKD
Gregg, L. P., & Hedayati, S. S. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-817080-9.00005-1 · Cited by 3
Self-citationPsychosocial Issues in Chronic Kidney Disease Patients
Cukor, D., Halen, N. V., & Kimmel, P. L. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-815876-0.00027-9 · Cited by 3
Ali, S., Ajmal, M. S., & Navaneethan, S. D. (2020) · Current Opinion in Nephrology & Hypertension · doi:10.1097/mnh.0000000000000633 · Cited by 3
Saleh-Arong, F. A.-H., Chokemaitree, N., Nata, N., Tasanavipas, P., Varothai, N., & Satirapoj, B. (2022) · Journal of Southeast Asian Medical Research · doi:10.55374/jseamed.v6i0.127 · Cited by 2
Fluyau, D., Kailasam, V. K., Kim, P., & Revadigar, N. (2025) · International Clinical Psychopharmacology · doi:10.1097/yic.0000000000000585 · Cited by 2
Psychiatric challenges and management in kidney transplantation
Cornelius, M. C. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-817080-9.00018-x · Cited by 2
The management of women with kidney disease
Lucas, A., & Taiwo, A. A. (2022) · Journal of the National Medical Association · doi:10.1016/j.jnma.2022.05.007 · Cited by 2
Coping Behaviors and Incident Kidney Disease
Novick, T. K., Custer, J., Zonderman, A. B., Evans, M. K., Hladek, M. D., Kuczmarski, M. F., Rathouz, P. J., & Crews, D. C. (2023) · Kidney360 · doi:10.34067/kid.0000000000000179 · Cited by 2
Bossola, M., Mariani, I., Antocicco, M., Pepe, G., Petrosino, A., & Stasio, E. D. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13113334 · Cited by 2
“…trial that included 201 patients with stage 3, 4, or 5 non-dialysis-dependent chronic kidney disease and at least moderate depressive symptoms, demonstrated that the use of sertraline vs. placebo did not result in a statistically significant difference in symptom improvement over 12 weeks [22].”
Collister, D., Bangdiwala, S. I., & Guyatt, G. H. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.08.018 · Cited by 2
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Эмировна, Г. А., Borodina, L., Pozdnyakov, S. A., & Тимербулатов, И. Ф. (2024) · Neuroscience and Behavioral Physiology · doi:10.1007/s11055-024-01716-5 · Cited by 1
Interdisciplinary Care for Geriatric Syndromes in CKD
Subash, A., Levinson, M., Bonnet, K. R., Hall, R. K., Saeed, F., Liu, C., Chatterjee, T. S., Mixon, A. S., Gould, E. R., Horst, S., et al. (2025) · Clinical Journal of the American Society of Nephrology · doi:10.2215/cjn.0000000658 · Cited by 1
“28 Except for treatments for depressive symptoms, there remains a dearth of interventions for functional decline or other symptom burden in CKD. 29 This is an important gap, as the hemodialysis facility offers a setting in which certain interventions could be more readily delivered as compared with…”
Ducharlet, K., Brennan, F. P., Raj, R., Ogivly, C., Stallworthy, E., Li, K. C., Kennard, A. L., Bob, S., Scholes-Robertson, N. J., Pais, R., et al. (2026) · Internal Medicine Journal · doi:10.1111/imj.70463 · Cited by 2
The landscape of psychiatric illness in CKD and ESRD
Won, A., & Kimmel, P. L. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-817080-9.00003-8 · Cited by 1
Claros-Erazo, M., Li, H., Schulman, I. H., & Musselman, D. L. (2021) · Personalized Medicine in Psychiatry · doi:10.1016/j.pmip.2021.100083 · Cited by 1
Depression and clinical outcomes in CKD: do anti-depressants play a role? (EQUAL study)
Chilcot, J., Picariello, F., & Farrington, K. (2022) · Clinical Kidney Journal · doi:10.1093/ckj/sfac080 · Cited by 1
Metadata
- Authors
- Hedayati, S. S., Gregg, L. P., Carmody, T., Jain, N., Toups, M., Rush, A. J., Toto, R. D., & Trivedi, M. H.
- Affiliations
- VA North Texas Health Care System (US)
- The University of Texas Southwestern Medical Center (US)
- Central Arkansas Veterans Healthcare System (US)
- The University of Texas at Austin (US)
- Duke University (US)
- Corresponding author
- Hedayati, S. Susan
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2017-11-21
- Volume
- 318
- Issue
- 19
- Pages
- 1876
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC5710375
- OpenAlex
- W2766107670
- Cited by
- 129
- References
- 45
- Citations by year
- 2026: 8 · 2025: 11 · 2024: 16 · 2023: 10 · 2022: 12 · 2021: 14 · 2020: 15 · 2019: 19 · 2018: 22 · 2017: 1
- FWCI
- 10.88
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs (I01 CX000217)
- National Institutes of Health (UL1TR001105)
- National Institute of Mental Health (K23MH104768)
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK085512, P30DK079328)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
- Health Sciences › Medicine › Psychiatry and Mental health › Mental Health Treatment and Access
- Keywords
- sertraline, chronic kidney disease, major depressive disorder, depressive symptoms, selective serotonin reuptake inhibitors, antidepressant efficacy, quality of life, adverse events, predialysis, CAST trial, adverse drug reactions, drug safety in renal impairment
- MeSH terms
- Adult, Antidepressive Agents, Depression, Major Depressive Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Quality of Life, Treatment Outcome, Selective Serotonin Reuptake Inhibitors, Sertraline, Renal Insufficiency, Chronic
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