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Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial.
Clin J Am Soc Nephrol 2017; 12(2):280-286CJ

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.

Authors+Show Affiliations

Due to the number of contributing authors, the affiliations are provided in the Supplemental Material. ken.farrington@nhs.net.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28126706

Citation

Friedli, Karin, 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 : CJASN, vol. 12, no. 2, 2017, pp. 280-286.
Friedli K, Guirguis A, Almond M, et al. Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial. Clin J Am Soc Nephrol. 2017;12(2):280-286.
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 Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial. Clinical Journal of the American Society of Nephrology : CJASN, 12(2), pp. 280-286. doi:10.2215/CJN.02120216.
Friedli K, et al. Sertraline Versus Placebo in Patients With Major Depressive Disorder Undergoing Hemodialysis: a Randomized, Controlled Feasibility Trial. Clin J Am Soc Nephrol. 2017 02 7;12(2):280-286. PubMed PMID: 28126706.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: 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, Y1 - 2017/01/26/ PY - 2016/02/24/received PY - 2016/10/19/accepted PY - 2017/1/28/pubmed PY - 2017/12/21/medline PY - 2017/1/28/entrez KW - Antidepressive Agents KW - Controlled Clinical Trials, Randomized KW - Depressive Disorder, Major KW - Double-Blind Method KW - Feasibility Studies KW - Follow-Up Studies KW - Humans KW - Personality Inventory KW - Placebos KW - Psychiatric Status Rating Scales KW - Risk Assessment KW - Sertraline KW - depression KW - hemodialysis KW - renal dialysis SP - 280 EP - 286 JF - Clinical journal of the American Society of Nephrology : CJASN JO - Clin J Am Soc Nephrol VL - 12 IS - 2 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. SN - 1555-905X UR - https://www.unboundmedicine.com/medline/citation/28126706/Sertraline_Versus_Placebo_in_Patients_with_Major_Depressive_Disorder_Undergoing_Hemodialysis:_A_Randomized_Controlled_Feasibility_Trial_ L2 - http://cjasn.asnjournals.org/cgi/pmidlookup?view=long&amp;pmid=28126706 DB - PRIME DP - Unbound Medicine ER -