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dc.contributor.authorFriedli, Karin
dc.contributor.authorGuirguis, Ayman
dc.contributor.authorAlmond, Michael
dc.contributor.authorDay, Clara
dc.contributor.authorChilcot, Joseph
dc.contributor.authorDa Silva-Gane, Maria
dc.contributor.authorDavenport, Andrew
dc.contributor.authorFineberg, Naomi A
dc.contributor.authorSpencer, Benjamin
dc.contributor.authorWellsted, David
dc.contributor.authorFarrington, Ken
dc.date.accessioned2018-02-13T17:15:38Z
dc.date.available2018-02-13T17:15:38Z
dc.date.issued2017-02-07
dc.identifier.citationFriedli , K , Guirguis , A , Almond , M , Day , C , Chilcot , J , Da Silva-Gane , M , Davenport , A , Fineberg , N A , Spencer , B , Wellsted , D & 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 , vol. 12 , no. 2 , pp. 280-286 . https://doi.org/10.2215/CJN.02120216
dc.identifier.issn1555-9041
dc.identifier.otherPURE: 13323914
dc.identifier.otherPURE UUID: f6e34913-da57-4284-9f3e-5c19c7597501
dc.identifier.otherPubMed: 28126706
dc.identifier.otherPubMedCentral: PMC5293327
dc.identifier.otherScopus: 85017159124
dc.identifier.urihttp://hdl.handle.net/2299/19779
dc.descriptionThis 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.
dc.description.abstractBACKGROUND 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.en
dc.format.extent7
dc.language.isoeng
dc.relation.ispartofClinical Journal of the American Society of Nephrology
dc.subjectAdult
dc.subjectAged
dc.subjectAntidepressive Agents
dc.subjectDepressive Disorder, Major
dc.subjectDouble-Blind Method
dc.subjectFeasibility Studies
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectMedication Adherence
dc.subjectMiddle Aged
dc.subjectPatient Dropouts
dc.subjectPsychiatric Status Rating Scales
dc.subjectRenal Dialysis
dc.subjectRenal Insufficiency, Chronic
dc.subjectSertraline
dc.subjectTreatment Outcome
dc.subjectJournal Article
dc.subjectMulticenter Study
dc.subjectRandomized Controlled Trial
dc.titleSertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis : A Randomized, Controlled Feasibility Trialen
dc.contributor.institutionCentre for Health Services and Clinical Research
dc.contributor.institutionDepartment of Psychology and Sports Sciences
dc.contributor.institutionSchool of Life and Medical Sciences
dc.contributor.institutionDepartment of Pharmacy, Pharmacology and Postgraduate Medicine
dc.contributor.institutionBasic and Clinical Science Unit
dc.description.statusPeer reviewed
rioxxterms.versionAM
rioxxterms.versionofrecordhttps://doi.org/10.2215/CJN.02120216
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue


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