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


CONCLUSIONS
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.


BACKGROUND
ISRCTN registry ISRCTN06146268 and EudraCT reference: 2012-000547-27.
Centre 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.
Karin
K
Friedli
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff - On - Sea, Essex, SSO ORY, UK. mike.almond@southend.nhs.uk.|Postgraduate Medical School, University of Hertfordshire, College Lane Campus, Hatfield, AL10 9AB, UK. mike.almond@southend.nhs.uk.
Michael
M
Almond
Department 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.
Clara
C
Day
Health 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.
Joseph
J
Chilcot
Centre 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.|Renal Unit, Lister Hospital, East & North Herts NHS Trust, Coreys Mill Lane, Stevenage, SG1 4AB, UK. maria.dasilvagane@nhs.net.
Maria da Silva
Mda S
Gane
University College London Centre for Nephrology, Royal Free Hampstead NHS Trust, Rowland Hill Street, London, NW3 2PF, UK. andrewdavenport@nhs.net.
Andrew
A
Davenport
Renal Unit, Lister Hospital, East & North Herts NHS Trust, Coreys Mill Lane, Stevenage, SG1 4AB, UK. a.guirguis3@herts.ac.uk.|Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Welwyn Garden City, AL8 6HG, UK. a.guirguis3@herts.ac.uk.|Postgraduate Medical School, University of Hertfordshire, College Lane Campus, Hatfield, AL10 9AB, UK. a.guirguis3@herts.ac.uk.
Ayman
A
Guirguis
Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Welwyn Garden City, AL8 6HG, UK. naomi.fineberg@btinternet.com.|Postgraduate Medical School, University of Hertfordshire, College Lane Campus, Hatfield, AL10 9AB, UK. naomi.fineberg@btinternet.com.
Naomi
N
Fineberg
Department 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.|South London and Maudsley NHS Foundation Trust, Maudsley Hospital, Denmark Hill, London, SE5 8AZ, UK. benjamin.spencer@kcl.ac.uk.
Benjamin
B
Spencer
Centre 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.
David
D
Wellsted
Renal Unit, Lister Hospital, East & North Herts NHS Trust, Coreys Mill Lane, Stevenage, SG1 4AB, UK. ken.farrington@nhs.net.|Postgraduate Medical School, University of Hertfordshire, College Lane Campus, Hatfield, AL10 9AB, UK. ken.farrington@nhs.net.
Ken
K
Farrington
D000928:Antidepressive Agents / Q000097:blood / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D010865:Pilot Projects; D006435:Renal Dialysis / Q000523:psychology*; D012107:Research Design; D020280:Sertraline / Q000097:blood / Q000627:therapeutic use*
D000928:Antidepressive Agents; D020280:Sertraline