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

Abstract

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.

Effect of Sertraline on Depressive Symptoms in Patients With Chronic Kidney Disease Without Dialysis Dependence

“…The retention rate in the current study was much higher than in other antidepressant trials involving patients with CKD, 27–34 comparable with large trials among participants without CKD. 12–14 There was a high percentage (92%) of patients who completed 6 weeks and 84%whocompleted 12 weeks (the entire trial duration).…”

“…27 Neither showed an antidepressant treatment effect. In one of these trials, 27 there was a higher withdrawal rate in the sertraline group due to adverse events. However, all participants in the present study underwent a structured psychiatric evaluation to rule in MDD and received an adequate dose and duration of treatment to elicit a clinically meaningful effect.…”

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

“…The full RCT protocol (trial registration number: ISRCTN06146268) [16] , and the outcome paper [17] , have been published elsewhere. Screening occurred in 709 HD patients of which a subsample ( n = 470) completed the MFI-20.…”

Prevalence and related factors of depressive symptoms in hemodialysis patients in northern China

“…Patients with CKD on hemodialysis (HD) have to endure physical discomforts related to their illness and have to face various stresses, family problems, which increasing the risk of depression [6]. The prevalence of depression is higher among patients receiving HD, with estimated rates ranging from 23 to 42% in the USA and Europe, and 45.9% in Taiwan [7–11]. Furthermore, clinical depression and subthreshold depressive symptoms are strongly associated with poor adherence to treatment, increased mortality and rates of hospitalization [12–16].…”