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Sertraline versus placebo in patients with major depressive disorder and undergoing haemodialysis: A randomised, controlled feasibility trial

Research output: Contribution to journalArticle

Karin Friedli, Ayman Guirguis, Michael Almond, Clara Day, Joseph Chilcot, Maria Da Silva-Gane, Andrew Davenport, Naomi Fineberg, Benjamin Spencer, David Wellsted, Ken Farrington

Original languageEnglish
Pages (from-to)280-286
JournalClinical Journal Of The American Society Of Nephrology
Volume12
Issue number2
Early online date26 Jan 2017
DOIs
Publication statusPublished - 7 Feb 2017

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Abstract

BACKGROUND AND OBJECTIVES: Depression is common in patients on haemodialysis (HD) but data on the benefits and risks of antidepressants in this setting are limited. We conducted a multicentre randomised double-blind placebo-controlled trial of sertraline over 6 months in HD patients with depression to determine study feasibility, safety and effectiveness. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS HD patients in five UK renal centres completed the Beck Depression Inventory II (BDI-II). Those scoring ≥ 16, not already on treatment for depression, were invited to undergo diagnostic interview to confirm major depressive disorder (MDD). Eligible patients with MDD were randomised to receive the study medication – either sertraline or placebo. Outcomes included recruitment and drop-out rates, change in the Montgomery-Åsberg Depression Rating Scale (MADRS) and BDI-II, and qualitative information to guide design of a large scale trial. RESULTS 709 patients were screened and enrolled between April 2013 and October 2014. 231(32.6%) had BDI-II ≥16, 58 (25%) of whom were already receiving treatment for depression; 63 underwent diagnostic interview; 37 were diagnosed with MDD; 30 were randomised. 21 completed the trial, 8/15 on sertraline and 13/15 on placebo (p=0.046). 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. BDI-II score fell from 29.1 ± 8.4 to 17.3 ± 12.4 (p<0.001) and MADRS score from 24.5 ± 4.1 to 10.3 ± 5.8 (p<0.001). There were no differences between sertraline and placebo groups. CONCLUSIONS Though small, this is the largest randomised trial to date of antidepressant medication in HD patients. 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 employ shorter follow-up and include depressed patients already taking antidepressants.

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