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 weeks.
“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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Depressive Symptoms Associate With Race and All-Cause Mortality in Patients With CKD
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“Recent trial data suggest that short-term antidepressant use among patients with CKD does not decrease depressive symptoms.(42) Similarly, in our study, exposure to antidepressant use did not attenuate the mortality risk associated with depressive symptoms among white, black, or Hispanic participants.”
BackgroundAntidepressant Usage in Haemodialysis Patients: Evidence of Sub‐Optimal Practice Patterns
Guirguis, A., Chilcot, J., Almond, M. K., Davenport, A., Wellsted, D. M., & Farrington, K. (2020) · Journal of Renal Care · doi:10.1111/jorc.12320 · Cited by 29 · see citing works
“In addition to the excess of adverse effects noted above (Friedli et al., 2017, Hedayati et al., 2017), use of antidepressants has also been associated with increased risks of altered mental status, falls, and fractures in older patients receiving HD (Ishida et al., 2019).”
BackgroundJayasooriya, N., Blackwell, J., Saxena, S., Bottle, A., Petersen, I., Creese, H., Hotopf, M., Pollok, R. C. G., & POP‐IBD study group (2022) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.16820 · Cited by 27 · see citing works
“0001 Ex- smoker 1037 (23) 3752 (37) 6591 (11) <0.”
Psychological Flexibility and Depression in Advanced CKD and Dialysis
Iida, H., Fujimoto, S., Wakita, T., Yanagi, M., Suzuki, T., Koitabashi, K., Yazawa, M., Kawarazaki, H., Ishibashi, Y., Shibagaki, Y., et al. (2020) · Kidney Medicine · doi:10.1016/j.xkme.2020.07.004 · Cited by 26 · see citing works
Use of Sertraline in Hemodialysis Patients
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Is successful treatment of depression in dialysis patients an achievable goal?
Chilcot, J., & Hudson, J. L. (2018) · Seminars in Dialysis · doi:10.1111/sdi.12755 · Cited by 23 · see citing works
“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.”
BackgroundMechanisms and treatment of late-life depression
Alexopoulos, G. S. (2021) · Focus · doi:10.1176/appi.focus.19304 · Cited by 22 · see citing works
Wiesinger, T., Kremer, S., Bschor, T., & Baethge, C. (2023) · Acta Psychiatrica Scandinavica · doi:10.1111/acps.13541 · Cited by 23 · see citing works
Addressing Mental Health in Pediatric Rheumatology
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“34 Work is needed to better understand the pharmacokinetics and efficacy of antidepressants in CKD.”
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“Evidence for the effectiveness of antidepressants in patients undergoing dialysis with depression and anxiety symptoms is low [12] and a recent large randomized controlled trial (RCT) found antidepressant therapy to be no better than placebo in non-dialysis-dependent patients with chronic kidney disease (CKD) [13].”
BackgroundEl‐Majzoub, S., Mucsi, I., Li, M., Moussaoui, G., Lipman, M. L., Looper, K. J., Novák, M., & Rej, S. (2018) · Psychosomatics · doi:10.1016/j.psym.2018.10.001 · Cited by 20 · see citing works
The Case for Selective Withdrawal of Antidepressants in Patients with Advanced Kidney Disease
Chilcot, J., & Farrington, K. (2019) · Journal of the American Society of Nephrology · doi:10.1681/asn.2019030308 · Cited by 19 · see citing works
Diagnosis and Management of Depression in Patients With Kidney Disease
Gregg, L. P., Trombello, J. M., McAdams, M. C., & Hedayati, S. S. (2021) · Seminars in Nephrology · doi:10.1016/j.semnephrol.2021.10.003 · Cited by 18 · see citing works
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“Participants were ineligible if they had a known cognitive or learning impairment, psychosis, and if they lacked English or Welsh language proficiency.”
Treatment of current depressive symptoms in dialysis patients: A systematic review and meta-analysis
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Effect of Acupuncture or Massage on Health-Related Quality of Life of Hemodialysis Patients
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Depression and the Effect of Sertraline on Inflammatory Biomarkers in Patients with Nondialysis CKD
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“The CKD Antidepressant Sertraline Trial (CAST) demonstrated that treatment of MDD with sertraline versus placebo for 12 weeks was not associated with an improvement in depressive symptoms, but did cause greater gastrointestinal side effects in individuals with CKD stages 3–5 (6).”
MethodSelf-citationChen, J., & Xie, S. (2018) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s159636 · Cited by 15 · see citing works
“1 in the placebo group and sertraline group, respectively.(22) The response and remission rates were 25.”
Comparative Safety of Antidepressants in Adults with CKD
Zhu, N., Xu, H., Lagerberg, T., Johnell, K., Carrero, J. J., & Chang, Z. (2023) · Clinical Journal of the American Society of Nephrology · doi:10.2215/cjn.0000000000000348 · Cited by 15 · see citing works
“12 The lack of evidence leaves clinicians in a dilemma regarding the management of depression in patients with CKD, potentially resulting in suboptimal care.”
BackgroundInflammation and Depression: the Neuroimmune Connection
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Self-citationJain, N., Wan, F., Kothari, M., Adelodun, A., Ware, J. L., Sarode, R., & Hedayati, S. S. (2019) · BMC Nephrology · doi:10.1186/s12882-019-1576-7 · Cited by 14 · see citing works
Self-citationThe efficacy of citalopram or escitalopram in patients with asthma and major depressive disorder
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The identification and management of depression in UK Kidney Care: Results from the Mood Maps Study.
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“Since evidence for antidepressants in people with CKD is inconclusive and adverse events are common, continued monitoring is vital (Chilcot & Farrington, 2019; Friedli et al., 2017; Hedayati et al., 2017; Pearce et al., 2023).”
Ma, S., Wang, W., Tang, M. A., Chen, H., & Ding, F. H. (2021) · Journal of International Medical Research · doi:10.1177/03000605211012661 · Cited by 13 · see citing works
“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.”
BackgroundPhillips, T., Harris, S., Aiyegbusi, O. L., Lucas, B. J., Benavente, M., Roderick, P. J., Cockwell, P., Kalra, P. A., Wheeler, D. C., Taal, M. W., et al. (2024) · Clinical Kidney Journal · doi:10.1093/ckj/sfae010 · Cited by 12 · see citing works
“The Chronic Kidney Disease Antidepressant Sertraline Trial ( CAST) [45 ] found that treatment with traditional anti-depressants for those with CKD had minimal effect on depressive symptoms or HRQoL in a NDD-CKD population, whilst a trial in those on dialysis showed improvement in depression scores…”
Social and Behavioral Barriers to Effective Care During the Transition to End-Stage Kidney Care
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Inflammation and Response to Sertraline Treatment in Patients With CKD and Major Depression
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Self-citationSleep-Related Disorders in Patients with CKD and Kidney Transplant Recipients
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Screening for Depression in People with Kidney Failure
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“Also, the validity of self-report questionnaire in nondialysis CKD patients was not undertaken, which becomes imperative as CKD comprises amuch larger segment of our patient population, and identifying risk in patients with earlier stages of disease would potentially lead to interventions that may prevent adverse outc…”
MethodInfluentialSelf-citationEffects of sertraline in the prevention of low blood pressure in patients undergoing hemodialysis
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Measuring and Modifying Psychological Distress in CKD: New Insights and Next Steps
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“Evidence of associations between depression and adverse outcomes in CKD have prompted randomized controlled trials aimed to alleviate depression in this patient group, but the causes and consequences of other components of psychological distress in CKD remain unexplored.(6,7) Thus, we know little of modifiable determi…”
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Risk Factors and Potential Treatments for Fatigue in Patients with Advanced CKD: A Narrative Review
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Treating Depression in Patients With Advanced CKD
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Treatment of Depression in CKD Patients with an SSRI
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“(3) presented a well designed, well conducted trial of pharmacologic therapy for depressed patients with CKD using the selective serotonin reuptake inhibitor (SSRI) sertraline.”
BackgroundInfluentialKremer, S., Wiesinger, T., Bschor, T., & Baethge, C. (2023) · Psychotherapy and Psychosomatics · doi:10.1159/000533494 · Cited by 8 · see citing works
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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].”
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“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 · see citing works
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 · see citing works
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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 5 · see citing works
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“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 · see citing works
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 · see citing works
Depression in patients undergoing hemodialysis: time to treat
Shirazian, S. (2019) · Kidney International · doi:10.1016/j.kint.2019.05.017 · Cited by 4 · see citing works
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 · see citing works
Self-citation(2021) · Wiley eBooks · doi:10.1002/9781119870203.mpg007 · Cited by 4 · see citing works
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 · see citing works
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 · see citing works
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 · see citing works
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 · see citing works
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 · see citing works
Chilcot, J., & Farrington, K. (2019) · Clinical Kidney Journal · doi:10.1093/ckj/sfz160 · Cited by 3 · see citing works
“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 · see citing works
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 · see citing works
Ali, S., Ajmal, M. S., & Navaneethan, S. D. (2020) · Current Opinion in Nephrology & Hypertension · doi:10.1097/mnh.0000000000000633 · Cited by 3 · see citing works
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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 · see citing works
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 · see citing works
Coping Behaviors and Incident Kidney Disease
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“…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].”
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Interdisciplinary Care for Geriatric Syndromes in CKD
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“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…”
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The landscape of psychiatric illness in CKD and ESRD
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Depression and clinical outcomes in CKD: do anti-depressants play a role? (EQUAL study)
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- 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 › Treatment of Major Depression
- Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
- Social Sciences › Psychology › Social Psychology › 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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Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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