Evidence map›Paper›PMID 26503099›Full record

Trial reportBMC nephrology2015

A study of sertraline in dialysis (ASSertID): a protocol for a pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis.

Karin Friedli, Michael Almond, Clara Day, Joseph Chilcot, Maria da Silva Gane, Andrew Davenport, Ayman Guirguis, Naomi Fineberg, Benjamin Spencer, David Wellsted and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC nephrology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Interventions for fatigue in people with kidney failure requiring dialysis.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Karin FriedliCentre for Lifespan and Chronic Illness Research, Department of Psychology, School of Life and Medical Sciences, University of Hertfordshire, College Lane Campus, Hatfield, AL10 9AB, UK. k.friedli1@herts.ac.uk.
Michael AlmondSouthend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff - On - Sea, Essex, SSO ORY, UK. mike.almond@southend.nhs.uk.
Clara DayDepartment of Renal Medicine, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham, B15 2TH, UK. clara.day@uhb.nhs.uk.
Joseph ChilcotHealth Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 5th floor Bermondsey Wing, Guy's Campus, London Bridge, London, SE1 9RT, UK. joseph.chilcot@kcl.ac.uk.
Maria da Silva GaneCentre for Lifespan and Chronic Illness Research, Department of Psychology, School of Life and Medical Sciences, University of Hertfordshire, College Lane Campus, Hatfield, AL10 9AB, UK. maria.dasilvagane@nhs.net.
Andrew DavenportUniversity College London Centre for Nephrology, Royal Free Hampstead NHS Trust, Rowland Hill Street, London, NW3 2PF, UK. andrewdavenport@nhs.net.
Ayman GuirguisRenal Unit, Lister Hospital, East & North Herts NHS Trust, Coreys Mill Lane, Stevenage, SG1 4AB, UK. a.guirguis3@herts.ac.uk.
Naomi FinebergHertfordshire Partnership University NHS Foundation Trust, Rosanne House, Welwyn Garden City, AL8 6HG, UK. naomi.fineberg@btinternet.com.
Benjamin SpencerDepartment of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Weston Education Centre, 10 Cutcombe Street, London, SE5 9RJ, UK. benjamin.spencer@kcl.ac.uk.
David WellstedCentre for Lifespan and Chronic Illness Research, Department of Psychology, School of Life and Medical Sciences, University of Hertfordshire, College Lane Campus, Hatfield, AL10 9AB, UK. d.m.wellsted@herts.ac.uk.
Ken FarringtonRenal Unit, Lister Hospital, East & North Herts NHS Trust, Coreys Mill Lane, Stevenage, SG1 4AB, UK. ken.farrington@nhs.net.
University of Hertfordshire · GBKing's College London · GBLister Hospital · GBMaudsley Hospital · GBRoyal Free London NHS Foundation Trust · GBUniversity Hospitals Birmingham NHS Foundation Trust · GB

Funding

Department of Health PB-PG-0110-21073Department of Health PB-PG-0909-19044Department of Health PB-PG-1112-29078
6 · The paper itself

Abstract

backgroundThe prevalence of depression in people receiving haemodialysis is high with estimates varying between 20 and 40 %. There is little research on the effectiveness of antidepressants in dialysis patients with the few clinical trials suffering significant methodological issues. We plan to carry out a study to evaluate the feasibility of conducting a randomised controlled trial in patients on haemodialysis who have diagnosed Major Depressive Disorder. METHODS/

designThe study has two phases, a screening phase and the randomised controlled trial. Patients will be screened initially with the Beck Depression Inventory to estimate the number of patients who score 16 or above. These patients will be invited to an interview with a psychiatrist who will invite those with a diagnosis of Major Depressive Disorder to take part in the trial. Consenting patients will be randomised to either Sertraline or placebo. Patients will be followed-up for 6 months. Demographic and clinical data will be collected at screening interview, baseline interview and 2 weeks, and every month (up to 6 months) after baseline. The primary outcome is to evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial in haemodialysis patients with depression. Secondary outcomes include estimation of the variability in the outcome measures for the treatment and placebo arms, which will allow for a future adequately powered definitive trial. Analysis will primarily be descriptive, including the number of patients eligible for the trial, drug exposure of Sertraline in haemodialysis patients and the patient experience of participating in this trial. DISCUSSION: There is an urgent need for this research in the dialysis population because of the dearth of good quality and adequately powered studies. Research with renal patients is particularly difficult as they often have complex medical needs. This research will therefore not only assess the outcome of anti-depressants in haemodialysis patients with depression but also the process of running a randomised controlled trial in this population. Hence, the outputs of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the efficacy of anti-depressants in patient on haemodialysis with depression.

trial registrationISRCTN registry ISRCTN06146268 and EudraCT reference: 2012-000547-27.

Indexed as

Antidepressive AgentsDouble-Blind MethodHumansKidney Failure, ChronicMajor Depressive DisorderPilot ProjectsRenal DialysisResearch DesignSertralineAntidepressive AgentsSertraline

Identifiers

PMID26503099
PMCPMC4621949
OpenAlexW1920460229

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.