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.

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.

(ISRCTN06146268).

BackgroundThe 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/DesignThe 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.DiscussionThere 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 registrationISRCTN registry ISRCTN06146268 and EudraCT reference: 2012-000547-27.

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.

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.

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.

SUMMARY 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.