ASSertID - A Study of Sertraline In Dialysis - Version 1
Research type
Research Study
Full title
A Pilot Randomised Controlled Trial of Drug Treatment for Depression in Patients undergoing Haemodialysis
IRAS ID
100774
Contact name
Ken Farrington
Sponsor organisation
East and North Hertfordshire NHS Trust
Eudract number
2012-000547-27
ISRCTN Number
n/a
Research summary
End stage renal disease (ESRD) is the complete or almost complete failure of the kidneys to function. Dialysis or kidney transplant are the only treatments for patients with ESRD to maintain life. Dialysis involves lengthy out-patient treatment sessions three times a week and can place a significant burden on the patient and their carers. Approximately 30% of ESRD patients on dialysis suffer from depression which impairs quality of life, is associated with the patient not taking their medication, increases risk of other illnesses and reduces life expectancy. Effective interventions exist for moderate to severe depression which include drugs like Selective Serotonin Reuptake Inhibitors (SSRIs). ESRD patients have unique medical and psychological pressures and it is unclear whether a SSRI is helpful in this group of patients. Due to the small number of limited studies, it is not known whether these drugs are effective or useable by ESRD patients. This study aims to evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial of Sertraline (an SSRI) in patients with ESRD on dialysis and mild to moderate major depressive disorder. The study will evaluate the number of ESRD patients eligible for a clinical trial, assessing the feasibility of conducting a randomised drug trial, testing the safety and drug exposure of Sertraline in patients with ESRD and exploring the patient experience of taking part in the clinical trial and taking medication.
REC name
London - Harrow Research Ethics Committee
REC reference
12/LO/1554
Date of REC Opinion
1 Nov 2012
REC opinion
Further Information Favourable Opinion