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

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Sertraline versus placebo in patients with major depressive disorder and undergoing haemodialysis : A randomised, controlled feasibility trial. / Friedli, Karin; Guirguis, Ayman; Almond, Michael ; Day, Clara; Chilcot, Joseph; Da Silva-Gane, Maria; Davenport, Andrew; Fineberg, Naomi; 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.

Research output: Contribution to journalArticle

Harvard

Friedli, K, Guirguis, A, Almond, M, Day, C, Chilcot, J, Da Silva-Gane, M, Davenport, A, Fineberg, N, Spencer, B, Wellsted, D & Farrington, K 2017, 'Sertraline versus placebo in patients with major depressive disorder and undergoing haemodialysis: A randomised, controlled feasibility trial', Clinical Journal Of The American Society Of Nephrology, vol. 12, no. 2, pp. 280-286. https://doi.org/10.2215/CJN.02120216

APA

Friedli, K., Guirguis, A., Almond, M., Day, C., Chilcot, J., Da Silva-Gane, M., ... Farrington, K. (2017). Sertraline versus placebo in patients with major depressive disorder and undergoing haemodialysis: A randomised, controlled feasibility trial. Clinical Journal Of The American Society Of Nephrology, 12(2), 280-286. https://doi.org/10.2215/CJN.02120216

Vancouver

Friedli K, Guirguis A, Almond M, Day C, Chilcot J, Da Silva-Gane M et al. Sertraline versus placebo in patients with major depressive disorder and undergoing haemodialysis: A randomised, controlled feasibility trial. Clinical Journal Of The American Society Of Nephrology. 2017 Feb 7;12(2):280-286. https://doi.org/10.2215/CJN.02120216

Author

Friedli, Karin ; Guirguis, Ayman ; Almond, Michael ; Day, Clara ; Chilcot, Joseph ; Da Silva-Gane, Maria ; Davenport, Andrew ; Fineberg, Naomi ; Spencer, Benjamin ; Wellsted, David ; Farrington, Ken. / Sertraline versus placebo in patients with major depressive disorder and undergoing haemodialysis : A randomised, controlled feasibility trial. In: Clinical Journal Of The American Society Of Nephrology. 2017 ; Vol. 12, No. 2. pp. 280-286.

Bibtex Download

@article{c79dd783354c4518b407917894f3417d,
title = "Sertraline versus placebo in patients with major depressive disorder and undergoing haemodialysis: A randomised, controlled feasibility trial",
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-{\AA}sberg 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.",
author = "Karin Friedli and Ayman Guirguis and Michael Almond and Clara Day and Joseph Chilcot and {Da Silva-Gane}, Maria and Andrew Davenport and Naomi Fineberg and Benjamin Spencer and David Wellsted and Ken Farrington",
year = "2017",
month = "2",
day = "7",
doi = "10.2215/CJN.02120216",
language = "English",
volume = "12",
pages = "280--286",
journal = "Clinical journal of the American Society of Nephrology : CJASN",
issn = "1555-9041",
publisher = "American Society of Nephrology",
number = "2",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - Sertraline versus placebo in patients with major depressive disorder and undergoing haemodialysis

T2 - A randomised, 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

AU - Spencer, Benjamin

AU - Wellsted, David

AU - Farrington, Ken

PY - 2017/2/7

Y1 - 2017/2/7

N2 - 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.

AB - 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.

U2 - 10.2215/CJN.02120216

DO - 10.2215/CJN.02120216

M3 - Article

VL - 12

SP - 280

EP - 286

JO - Clinical journal of the American Society of Nephrology : CJASN

JF - Clinical journal of the American Society of Nephrology : CJASN

SN - 1555-9041

IS - 2

ER -

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