Depression Symptoms in Haemodialysis Patients Predict All-Cause Mortality but Not Kidney Transplantation: A Cause-Specific Outcome Analysis.

Background: Depression is common in haemodialysis (HD) patients and associated with poor outcomes. Purpose: To evaluate whether depression symptoms predict survival and transplantation in a large sample of haemodialysis patients using cause-specific survival models. Methods: Survival data was collected between April 2013 and November 2015, as part of the screening phase of a multicentre randomised placebo-controlled trial of sertraline in HD patients. Depression was measured using the Beck Depression Inventory-II (BDI-II) and the Patient Health Questionnaire-9 (PHQ-9). Demographic and clinical data were collected via a self-report questionnaire and medical records. Competing risk survival analysis involved cause-specific and subdistribution hazard survival models. All models were adjusted for appropriate covariates including co-morbidity and C-reactive protein (CRP) in a subanalysis. Results: Of 707 cases available for analysis, there were 148 deaths. The mean survival time was 787.5 days. Cumulative survival at 12 months was 88.5%. During the study follow-up period, there were 92 transplants. The cumulative transplant event rate at 12 months was 7.8%. In separate adjusted models, depression symptoms predicted mortality (BDI-II HR = 1.03 95% CI 1.01, 1.04; PHQ-9 HR = 1.04 95% CI 1.01, 1.06). With respect to screening cut-off scores, a PHQ-9 ≥ 10 was associated with mortality (HR = 1.51 95% CI 1.01, 2.19) but not a BDI-II ≥ 16. Depression symptoms were not associated with time to transplantation in either cause-specific or subdistribution model. Conclusions: Consistent with past findings in HD patients, depression symptoms predicted survival but were not associated with kidney transplantation. Suitable treatments for depression need further evaluation, and their impact upon quality of life and clinical outcomes determined. Trial Registration Number: (ISRCTN06146268).

Scaling Hemodialysis Target Dose to Reflect Body Surface Area, Metabolic Activity, and Protein Catabolic Rate: A Prospective, Cross-sectional Study.

BACKGROUND: Women and small men treated by hemodialysis (HD) have reduced survival. This may be due to use of total-body water (V) as the normalizing factor for dialysis dosing. In this study, we explored the equivalent dialysis dose that would be delivered using alternative scaling parameters matching the current recommended minimum Kt/V target of 1.2. STUDY DESIGN: Prospective cross-sectional study. SETTING & PARTICIPANTS: 1,500 HD patients on a thrice-weekly schedule, recruited across 5 different centers. PREDICTORS: Age, sex, weight, race/ethnicity, comorbid condition level, and employment status. OUTCOMES: Kt was estimated by multiplying V by 1.2. Kt/body surface area (BSA), Kt/resting energy expenditure (REE), Kt/total energy expenditure (TEE) and Kt/normalized protein catabolic rate (nPCR) equivalent to a target Kt/V of 1.2 were then estimated by dividing Kt by the respective parameters. MEASUREMENTS: Anthropometry, HD adequacy details, and BSA were obtained by standard procedures. REE was estimated using a novel validated equation. TEE was calculated from physical activity data obtained using the Recent Physical Activity Questionnaire. nPCR was estimated using a standard formula. RESULTS: Mean BSA was 1.87m2; mean REE, 1,545kcal/d; mean TEE, 1,841kcal/d; and mean nPCR, 1.03g/kg/d. For Kt/V of 1.2, there was a wide range of equivalent doses expressed as Kt/BSA, Kt/REE, Kt/TEE, and Kt/nPCR. The mean equivalent dose was lower in women for all 4 parameters (P<0.001). Small men would also receive lower doses compared with larger men. Younger patients, those with low comorbidity, those employed, and those of South Asian race/ethnicity would receive significantly lower dialysis doses with current practice. LIMITATIONS: Cross-sectional study; physical activity data collected by an activity questionnaire. CONCLUSIONS: Current dosing practices may risk underdialysis in women, men of smaller body size, and specific subgroups of patients. Using BSA-, REE-, or TEE-based dialysis prescription would result in higher dose delivery in these patients.

A study of sertraline in dialysis (ASSertID): a protocol for a pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis.

BACKGROUND: The prevalence of depression in people receiving haemodialysis is high with estimates varying between 20 and 40 %. There is little research on the effectiveness of antidepressants in dialysis patients with the few clinical trials suffering significant methodological issues. We plan to carry out a study to evaluate the feasibility of conducting a randomised controlled trial in patients on haemodialysis who have diagnosed Major Depressive Disorder. METHODS/DESIGN: The study has two phases, a screening phase and the randomised controlled trial. Patients will be screened initially with the Beck Depression Inventory to estimate the number of patients who score 16 or above. These patients will be invited to an interview with a psychiatrist who will invite those with a diagnosis of Major Depressive Disorder to take part in the trial. Consenting patients will be randomised to either Sertraline or placebo. Patients will be followed-up for 6 months. Demographic and clinical data will be collected at screening interview, baseline interview and 2 weeks, and every month (up to 6 months) after baseline. The primary outcome is to evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial in haemodialysis patients with depression. Secondary outcomes include estimation of the variability in the outcome measures for the treatment and placebo arms, which will allow for a future adequately powered definitive trial. Analysis will primarily be descriptive, including the number of patients eligible for the trial, drug exposure of Sertraline in haemodialysis patients and the patient experience of participating in this trial. DISCUSSION: There is an urgent need for this research in the dialysis population because of the dearth of good quality and adequately powered studies. Research with renal patients is particularly difficult as they often have complex medical needs. This research will therefore not only assess the outcome of anti-depressants in haemodialysis patients with depression but also the process of running a randomised controlled trial in this population. Hence, the outputs of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the efficacy of anti-depressants in patient on haemodialysis with depression. TRIAL REGISTRATION: ISRCTN registry ISRCTN06146268 and EudraCT reference: 2012-000547-27.

Evidence that self-affirmation improves phosphate control in hemodialysis patients: a pilot cluster randomized controlled trial.

BACKGROUND: Hemodialysis patients are at risk of serious health complications, yet treatment non-adherence remains high. PURPOSE: Warnings about health risks associated with non-adherence may trigger defensive reactions. We studied whether an intervention based on self-affirmation theory (Steele 1988) reduced patients' resistance to health-risk information and improved adherence. METHODS: One hundred twelve patients either self-affirmed or completed a matched control task before reading about the risks associated with a lack of phosphate control. Serum phosphate was collected from baseline up to 12 months. RESULTS: Self-affirmed patients had significantly reduced serum phosphate levels at 1 and 12 months. However, contrary to the predictions derived from self-affirmation theory, self-affirmed participants and controls did not differ in their evaluation of the health-risk information, behavioural intention or self-efficacy. CONCLUSIONS: A low-cost, high-reach health intervention based on self-affirmation theory was shown to reduce serum phosphate over a 12 month period. Further work is required to identify mediators of the observed effects.

Apparent renal disease due to elevated creatinine levels associated with the use of boldenone.

The widespread use of reporting estimated glomerular filtration rate (eGFR) alongside serum creatinine has led to a heightened appreciation of renal disease. However, creatinine is recognized as an insensitive marker of true GFR and therefore can lead to misdiagnosis of renal dysfunction in the absence of true pathology. We report the case of a 37-year-old male referred due to abnormal eGFR and creatinine in the absence of clinical signs, symptoms or other biochemical abnormalities of renal disease. Subsequent investigations based on a high index of suspicion for exogenous substance abuse led to a novel observation of significantly raised creatinine due to the presence of boldenone, an equine anabolic steroid commonly abused in body building.

Professor Hugh MacLean: one of the first British military research nephrologists and the pioneer of the first United Kingdom veterans' renal clinic.

Few people have been as successful in bringing together basic research, clinical science, and a contribution to military medicine as Professor Hugh MacLean. However, today he is almost forgotten. During World War 1, practicing within the realms of the new field of renal medicine, with minimal resources and in a military hospital, he conducted one of the first large-scale Medical Research Committee investigations into war nephritis involving 60,000 subjects. After the war he set up and practiced, amongst other specialties, in the field of veteran medicine and established the concept of the one-stop renal clinic. After achieving significant academic recognition, he was unfortunately affected by mental health problems, possibly related to his wartime experiences, which brought an illustrious career to an untimely end.

Remote Access Therapy for Veterans With Psychological Problems: Current State of the Art.

INTRODUCTION: The past decade has seen both an increase in use and research into ways in which psychological therapy might be delivered remotely. Remote access therapy uses technology to deliver talking therapies. It is important to understand how remote technologies are being used as part of the therapeutic process and consider what effect this has on the success of therapeutic interventions. This review discusses what is currently known about the use of remote access therapy with a veteran population. Moreover, the review summarizes potential benefits and barriers to conducting therapy remotely. MATERIALS AND METHODS: This review was conducted to explore the use of remote access therapies with veterans. All available literature identified for this review focused on veteran cohorts from the US and UK. To meet search criteria, studies had to include veteran participants engaging with any form of talking therapy delivered remotely. A total of 15 studies met the inclusion criteria: two from the UK and 13 from the US. Searches were carried out during June and July 2019. RESULTS: A number of potential benefits to remote therapy delivery were observed in the research reviewed, including improved accessibility to therapy for people living in remote locations (providing infrastructure existed to facilitate the remote access technologies), increased flexibility of timing, and being able to undergo therapy alongside other life commitments. The studies also suggested that those involved in remote therapy found the technology accessible and easy to operate. Digital technologies could generally be relied upon and although there were some technical difficulties reported that these were generally not seen as a barrier to the use of remote technologies as a whole. Some limitations to using remote therapies were observed, such as the acceptability of remote therapy, particularly in the UK, and the willingness of practitioners to engage with digital technologies to facilitate remote therapy. There was also caution raised that the apparent cost effectiveness of delivering therapy remotely needs to be further investigated, particularly in relation to costs involved in enabling remote access technologies in locations where poor infrastructure exists. CONCLUSIONS: Overall, studies reported largely positive outcomes for veterans undergoing remote access therapy and in general participants did not find the therapeutic process compromised by remote delivery. Studies showed that remote access therapy is being conducted successfully in both the US and UK. There is, however, a need for more research into the use of remote access therapies to treat a wider range of psychological difficulties in veterans.

Antidepressant Usage in Haemodialysis Patients: Evidence of Sub-Optimal Practice Patterns.

BACKGROUND: Depression is common in patients on haemodialysis and associated with adverse outcomes. Antidepressant use is widespread though evidence of efficacy is limited. OBJECTIVES: To study antidepressant management practices in patients on haemodialysis with reference to NICE guidelines on management of depression in adults with chronic physical health problems. DESIGN: Prospective, multicentre, longitudinal cohort study with 6-15 month follow-up. PARTICIPANTS: Patients on haemodialysis established on antidepressant medication. MEASUREMENTS: Baseline assessment of mood was undertaken using Beck Depression Inventory (BDI-II). Demographic, clinical and medication data were also collected. Changes in clinical and life circumstances and medication during follow-up were recorded. At follow-up, BDI-II was reassessed and diagnostic psychiatric assessment undertaken. RESULTS: Forty-one patients were studied. General practitioners were the main prescribers (68%). Ten agents were in use, the commonest being Citalopram (39%). Doses were often suboptimal. At baseline, 30 patients had high BDI-II scores (≥16) and 22 remained high at follow-up. Eleven had BDI-II < 16 at baseline. In five, this increased on follow-up to ≥16. Sixteen patients (39%) had no medication review during follow-up, 14 (34%) had a dose review, and 11 (27%) a medication change. On psychiatric assessment at follow-up, eight patients had current major depressive disorder (MDD), seven recurrent and 20 evidence of past MDD. Six displayed no evidence of ever having MDD. CONCLUSIONS: Antidepressant management in patients on haemodialysis reflected poor drug selection, overprescription, under-dosing and inadequate follow-up suggesting sub-optimal adherence to NICE guidelines. Most patients had high depression scores at follow-up. Antidepressant use in haemodialysis requires reappraisal.

Comparison of characteristics of centers practicing incremental vs. conventional approaches to hemodialysis delivery - postdialysis recovery time and patient survival.

INTRODUCTION: Conventional haemodialysis (HD) involves treatment times of around 4 hours thrice weekly, taking no account of residual kidney function (RKF). In incremental HD the frequency and duration of dialysis sessions are individualized according to RKF. There are no studies comparing these approaches. We utilized data from a recent multicenter study to compare patient characteristics and outcomes between a center practicing incremental HD and others using a conventional approach. METHODS: Seven hundred and nine patients attending for routine outpatient HD in five UK centers were studied. One center practiced incremental dialysis (n = 254) and four conventional HD (n = 455). Data collected included demographics, comorbidity, dialysis parameters, routine biochemistry and hematology, recovery time postdialysis, and Beck Depression Inventory-II score (BDI-II). Patients were followed for a minimum of 12 months. FINDINGS: Pre- and postdialysis BP, serum calcium and phosphate were higher in the incremental center, whilst sessional Kt/Vurea was lower (all P < 0.001), as was the proportion of patients with a mean postdialysis BP <100 mmHg (P = 0.011). Patients recovered from their HD session more quickly in the incremental center, with significantly more patients reporting recovery within 1 and 4 hours Short-term survival was significantly better in the incremental center both unadjusted and adjusted for age, gender, ethnicity, dialysis vintage, anuria, history of cancer, heart disease, diabetes mellitus, body mass index, serum albumin, BDI-II score, and sessional Kt/V. DISCUSSION: The association between incremental dialysis, shorter postdialysis recovery times and improved short-term survival may be related to reduced haemodynamic stress as a consequence of less intensive ultrafiltration and reduced length of dialysis sessions. Prospective studies are required to test this hypothesis.

The Beck Depression Inventory requires modification in scoring before use in a haemodialysis population in the UK.

BACKGROUND: There are high rates of mental illness, especially depression in people with end-stage renal disease (ESRD) on haemodialysis (HD). Depression can be difficult to diagnose, as depression and the medical problem share many symptoms. It is essential that the diagnosis of a depressive illness be accurately made in order that subsequent psychiatric management can occur. This is the first study done in the UK which aims to validate a simple method for detecting depression, the Beck Depression Inventory (BDI), in people on HD against a structured psychiatric interview with a trained psychiatrist using the ICD-10 classification of depression. The BDI is validated in a normal population, but in patients with physical ill health there has been a difficulty in defining appropriate cut-off scores. METHODS: Patients dialysing for over 3 months from a single HD unit were eligible for participation. Patients were excluded if a known psychiatric illness existed or if they were receiving medication for a psychiatric illness. Patients who had a recent major illness requiring hospitalisation were excluded. 57 consenting participants completed the self-reported BDI. Within the next week a psychiatrist carried out a clinical interview to diagnose depression, based on the ICD-10 classification of a depressive disorder. Patients were classified as not being depressed or having mild, moderate or severe depression according to their BDI score or the ICD-10 classification. RESULTS: The BDI gave more scores for depression and more severe scores than ICD-10. 30 cases had scores which agreed, 27 cases resulted in a higher BDI score than the ICD-10 classification, in no case was the ICD-10 classification more severe (Wilcoxon signed rank test p < 0.001). All 7 diagnosed as being depressed by clinical interview were also depressed by BDI, although in 2 cases the BDI worsened the depression score. CONCLUSIONS: Using the general population cut-off score, the BDI significantly overdiagnosed depression in this HD population. This study defines a BDI cut-off score which more reliably detects major depression in a HD population. Unrecognised depression remains high in those with no known psychiatric illness within the HD populations.

100 years of the Royal Air Force's contribution to medicine: providing care in the air and delivering care by air.

The Royal Air Force (RAF) came into being during World War I as the world's first independent air force on the 1 April 1918, amalgamating elements of the Royal Flying Corps (RFC), itself established in 1912 and the Royal Naval Air Service which had formally separated from the Admiralty's administered Air Wing of the RFC in 1915. The RAF therefore celebrates its 100th anniversary in the same year that the Royal College of Physicians of London celebrates its 500th. This article will cover the contribution that military aviation has made to medicine since 1913 with the emphasis of three examples focusing on delivering care by air, providing care in the air and in developing systems for supporting aircrew or patients at the extremes of physiological stress.

A virtual clinic to improve long-term outcomes in chronic kidney disease.

Chronic kidney disease (CKD) is common. A small proportion of patients with CKD progress to require interventions, which may include dialysis. Monitoring patients with CKD is supported by national guidelines. Monitoring systems to plan management of CKD vary in form. A novel monitoring system, the virtual CKD clinic (VC) was introduced at our hospital. The VC is a non-face-to-face results review of patients with CKD. We found that the VC was an effective monitoring system. None of the patients from the VC required emergency dialysis, suggesting robust surveillance. Survival was similar to patients with CKD discharged to primary care.

Indexing dialysis dose for gender, body size and physical activity: Impact on survival.

Current practice basing dialysis dose on urea distribution volume (V) has been questioned. We explored the impact on survival of scaling dialysis dose (Kt) to parameters reflective of metabolic activity. In a multicentre prospective cohort study of 1500 patients on thrice-weekly haemodialysis, body surface area (BSA) and resting energy expenditure (REE) were estimated using validated equations and physical activity by the Recent Physical Activity Questionnaire. Total energy expenditure (TEE) was estimated from REE and physical activity data. Kt was calculated from delivered (single-pool Kt/V)*Watson V. Kt/BSA, Kt/REE and Kt/TEE were then calculated at baseline and 6 monthly during follow-up for 2 years. In adjusted Cox models Kt/TEE, Kt/BSA, Kt/REE, in that order, had lower hazard ratios for death than single-pool Kt/V. On the basis of adjusted survival differences, putative minimum target doses were estimated for Kt/BSA as 27119 ml/m2 and Kt/TEE as 25.79 ml/kcal. We identified spKt/V values equivalent to these estimated targets, ranging from 1.4 to 1.8 in patient groups based on gender, body size and physical activity. For sedentary patients, the minimum target dose was 1.4 for large males, 1.5 for small males and 1.7 for women. For active patients the target was 1.8 irrespective of gender and body-weight. Patients achieving these individualised minimum targets had greater adjusted two-year survival compared to those achieving conventional minimum targets. Metabolic activity related parameters, such as Kt/TEE and Kt/BSA, may have a clinically important role in scaling haemodialysis dose. Using such parameters or their spKt/V equivalents to adjust minimum target doses based on gender, body size and habitual physical activity may have a positive impact on survival.

Developing cellulosic waste products as platform chemicals: protecting group chemistry of α-glucoisosaccharinic acid.

Alpha and beta-glucoisosaccharinic acids ((2S,4S)-2,4,5-trihydroxy-2-(hydroxymethyl)pentanoic acid and (2R,4S)-2,4,5-trihydroxy-2-(hydroxymethyl)pentanoic acid) which are produced when cellulosic materials are treated with aqueous alkali are potentially valuable platform chemicals. Their highly functionalised carbon skeleton, with fixed chirality at C-2 and C-4, makes them ideal starting materials for use in synthesis. In order to assess the potential of these saccharinic acids as platform chemicals we have explored the protecting group chemistry of the lactone form of alpha-glucoisosaccharinic acid (α-GISAL). We report here the use of single and multiple step reaction pathways leading to the regioselective protection of the three different hydroxyl groups of α-GISAL. We report strategies for protecting the three different hydroxyl groups individually or in pairs. We also report the synthesis of a range of tri-O-protected α-GISAL derivatives where a number of the products contain orthogonal protecting groups.

Self-reported depression symptoms in haemodialysis patients: Bi-factor structures of two common measures and their association with clinical factors.

OBJECTIVE: To validate the factor structure of two common self-report depression tools in a large sample of haemodialysis (HD) patients and to examine their demographic and clinical correlates, including urine output, history of depression and transplantation. METHODS: Factor structures of the Beck Depression Inventory (BDI-II) and Patient Health Questionnaire (PHQ-9) were evaluated using confirmatory factor analysis (CFA). Data was utilised from the screening phase (n = 709) of a placebo-controlled feasibility randomised control trial (RCT) of sertraline in HD patients with mild to moderate Major Depressive Disorder. Alternative factor models including bi-factor models for the BDI-II and PHQ-9 were evaluated. Coefficient omega and omega-hierarchical were calculated. RESULTS: For both measures, bi-factor measurement models had the overall best fit to the data, with dominant general depression factors. Omega-hierarchical for the general BDI-II and PHQ-9 factors was 0.94 and 0.88 respectively. Both general factors had high reliability (coefficient omega = 0.97 and 0.94 respectively) and explained over 85% of the explained common variance within their respective models. BDI-II and PHQ-9 general depression factors were negatively associated with age and urine output and positively with a history of depression, antidepressant use within the last 3 months and a history of failed transplantation. In adjusted regression models, age, urine output and a history of depression remained significant. CONCLUSIONS: These data suggest that both the BDI-II and PHQ-9 are sufficiently unidimensional to warrant the use of a total score. Younger age, lower urine output and a history of depression appear consistent correlates of depression severity among HD patients.

Postdialysis recovery time is extended in patients with greater self-reported depression screening questionnaire scores.

INTRODUCTION: Most patients take time to recover after a hemodialysis (HD) session. It has been suggested that recovery time is associated with intradialytic hypotension and rapid solute clearances. Other studies have reported a linkage to depression. We investigated the association between recovery time and intradialytic hypotension and depression. METHODS: In five UK HD units, we screened for depressive symptoms using the Beck depression inventory-II, Patient Health Questionnaire, and recorded sessional blood pressures and Kt/Vurea. FINDINGS: Seven hundred and one HD patients were studied; 63.6% male, mean age 64.1 ± 16.6 years, 33.5% diabetic. About 24.1% recovered in <1 hour, 27% 1-4 hours, 15.4% 4-8 hours, 10.7% 8-12 hours, and 22.8% after 12 hours. Systolic blood pressure fell by ≥20 mmHg in 30.9% postdialysis, and to <100 mmHg in 7.6%. In multivariate analysis, patients with recovery times >1 hour were more likely to be female, have high self-reported Beck depression inventory-II scores, a past medical history of depression, and be living without a partner. Longer recovery times were also associated with very low postdialysis systolic blood pressures (<100 mmHg), and higher body weight. However, the model predicted only 18% of the variation in recovery times. We found no association between recovery times and short-term mortality risk. DISCUSSION: Prolonged postdialysis recovery times are associated with higher self-reported depression scores, and very low postdialysis blood pressure. Future studies investigating changes in dialysis practice and recovery times will need to target strategies to prevent intradialytic hypotension and adjust for patient psychological status.

Measuring Fatigue Using the Multidimensional Fatigue Inventory-20: A Questionable Factor Structure in Haemodialysis Patients.

BACKGROUND/AIMS: Fatigue is recognised as a common and burdensome symptom among dialysis patients. A growing body of research is devoted to understanding fatigue in advanced kidney disease, yet its measurement is challenging within this context. Our aim was to evaluate the factor structure underlying the multidimensional fatigue inventory (MFI-20) and to examine its associations with clinical factors and mood. METHODS: Data was evaluated for confirmatory factor analysis (CFA) from the screening phase of a multicentre randomised placebo-controlled trial of sertraline in haemodialysis (HD) patients. Four hundred seventy patients completed the MFI-20, which purports to measure 5 components of fatigue (general fatigue, mental fatigue, physical fatigue, reduced motivation and reduced activity). CFA models were evaluated in MPlus 7.3 using the robust maximum likelihood (MLR) estimation. RESULTS: The evaluation of the original 5 factors revealed low internal reliability for the general factor and reduced activity, and high intercorrelations between all sum scores. CFA revealed poor model fit for the original 5-factor MFI-20 model (confirmatory fit index = 0.738; Tucker-Lewis index = 0.689; root mean squared error of approximation = 0.101). Alternative models, including 1, 3 and bi-factor models all demonstrated poor fit to the data. No reliable factor model was confirmed prohibiting the examination of factors associated with fatigue. CONCLUSIONS: We were not able to confirm the factor structure of the MFI-20 in a large sample of HD patients. Certain items may lack suitable face validity in this context.

Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial.

BACKGROUND AND OBJECTIVES: Depression is common in patients on hemodialysis, but data on the benefits and risks of antidepressants in this setting are limited. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of sertraline over 6 months in patients on hemodialysis with depression to determine study feasibility, safety, and effectiveness. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patients on hemodialysis at five United Kingdom renal centers completed the Beck Depression Inventory II. Those scoring ≥16 and not already on treatment for depression were invited to undergo diagnostic interview to confirm major depressive disorder. Eligible patients with major depressive disorder were randomized to receive the study medication-either sertraline or placebo. Outcomes included recruitment and dropout rates, change in the Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory II, and qualitative information to guide design of a large-scale trial. RESULTS: In total, 709 patients were screened and enrolled between April of 2013 and October of 2014; 231 (32.6%) had Beck Depression Inventory II scores ≥16, and 68 (29%) of these were already receiving treatment for depression. Sixty-three underwent diagnostic interview, 37 were diagnosed with major depressive disorder, and 30 were randomized; 21 completed the trial: eight of 15 on sertraline and 13 of 15 on placebo (P=0.05). Dropouts due to adverse and serious adverse events were greater in the sertraline group. All occurred in the first 3 months. Over 6 months, depression scores improved in both groups. Beck Depression Inventory II score fell from 29.1±8.4 to 17.3±12.4 (P<0.001), and Montgomery-Asberg Depression Rating Scale score fell from 24.5±4.1 to 10.3±5.8 (P<0.001). There were no differences between sertraline and placebo groups. CONCLUSIONS: Although small, this is the largest randomized trial to date of antidepressant medication in patients on hemodialysis. Our results highlight recruitment issues. No benefit was observed, but trial size and the substantial dropout render consideration of benefit inconclusive. A definitive trial could use shorter follow-up and include depressed patients already taking antidepressants.