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Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis : A Randomized, Controlled Feasibility Trial. / Friedli, Karin; Guirguis, Ayman; Almond, Michael; Day, Clara; Chilcot, Joseph; Da Silva-Gane, Maria; Davenport, Andrew; Fineberg, Naomi A; Spencer, Benjamin; Wellsted, David; Farrington, Ken.

In: Clinical Journal of the American Society of Nephrology, Vol. 12, No. 2, 07.02.2017, p. 280-286.

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Friedli, Karin ; Guirguis, Ayman ; Almond, Michael ; Day, Clara ; Chilcot, Joseph ; Da Silva-Gane, Maria ; Davenport, Andrew ; Fineberg, Naomi A ; Spencer, Benjamin ; Wellsted, David ; Farrington, Ken. / Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis : A Randomized, Controlled Feasibility Trial. In: Clinical Journal of the American Society of Nephrology. 2017 ; Vol. 12, No. 2. pp. 280-286.

Bibtex

@article{f6e34913da5742849f3e5c19c7597501,
title = "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.",
keywords = "Adult, Aged, Antidepressive Agents, Depressive Disorder, Major, Double-Blind Method, Feasibility Studies, Female, Humans, Male, Medication Adherence, Middle Aged, Patient Dropouts, Psychiatric Status Rating Scales, Renal Dialysis, Renal Insufficiency, Chronic, Sertraline, Treatment Outcome, Journal Article, Multicenter Study, Randomized Controlled Trial",
author = "Karin Friedli and Ayman Guirguis and Michael Almond and Clara Day and Joseph Chilcot and {Da Silva-Gane}, Maria and Andrew Davenport and Fineberg, {Naomi A} and Benjamin Spencer and David Wellsted and Ken Farrington",
note = "This document is the Accepted Manuscript version of the following article: Karin Friedli, et al, {\textquoteleft}Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial{\textquoteright}, Clinical Journal of the American Society of Nephrology, Vol. 12 (2): 280-286, February 2017. The final, published version is available online at DOI: https://doi.org/10.2215/​CJN.02120216. ",
year = "2017",
month = feb,
day = "7",
doi = "10.2215/CJN.02120216",
language = "English",
volume = "12",
pages = "280--286",
journal = "Clinical Journal of the American Society of Nephrology",
issn = "1555-9041",
publisher = "American Society of Nephrology",
number = "2",

}

RIS

TY - JOUR

T1 - Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis

T2 - A Randomized, Controlled Feasibility Trial

AU - Friedli, Karin

AU - Guirguis, Ayman

AU - Almond, Michael

AU - Day, Clara

AU - Chilcot, Joseph

AU - Da Silva-Gane, Maria

AU - Davenport, Andrew

AU - Fineberg, Naomi A

AU - Spencer, Benjamin

AU - Wellsted, David

AU - Farrington, Ken

N1 - This document is the Accepted Manuscript version of the following article: Karin Friedli, et al, ‘Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial’, Clinical Journal of the American Society of Nephrology, Vol. 12 (2): 280-286, February 2017. The final, published version is available online at DOI: https://doi.org/10.2215/​CJN.02120216.

PY - 2017/2/7

Y1 - 2017/2/7

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Antidepressive Agents

KW - Depressive Disorder, Major

KW - Double-Blind Method

KW - Feasibility Studies

KW - Female

KW - Humans

KW - Male

KW - Medication Adherence

KW - Middle Aged

KW - Patient Dropouts

KW - Psychiatric Status Rating Scales

KW - Renal Dialysis

KW - Renal Insufficiency, Chronic

KW - Sertraline

KW - Treatment Outcome

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

U2 - 10.2215/CJN.02120216

DO - 10.2215/CJN.02120216

M3 - Article

C2 - 28126706

VL - 12

SP - 280

EP - 286

JO - Clinical Journal of the American Society of Nephrology

JF - Clinical Journal of the American Society of Nephrology

SN - 1555-9041

IS - 2

ER -