A pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis

East and North Herts NHS Trust (ENHT) (UK)0 sites30 target enrollmentMay 1, 2014

Overview

Registry

who.int

Start Date

May 1, 2014

End Date

February 28, 2015

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

East and North Herts NHS Trust (ENHT) (UK)

•1\. Screening eligibility:
•1\.1\. Patients with ESRD and receiving haemodialysis. They will have started dialysis at least 3 months ago and have continued to receive dialysis in the past 3 months prior to the invitation to take part in this study
•1\.2\. Adults aged 18 or over
•1\.3\. Patients who speak and read English sufficiently well to complete questionnaires
•2\. Trial eligibility:
•2\.1\. Patients with a Beck Depression Inventory (BDI\-II) of 16 or above
•2\.2\. Patients who, according to the CI/PIs, have a prognosis of more than 1 year
•2\.3\. Patients with a diagnosis of mild to moderate Major Depressive Disorder according to a Diagnostic and Statistical Manual of Mental Disorders (DSM) IV interview conducted by a research psychiatrist
•2\.4\. Patients who score 18 or above on the Montgomery\-Asberg Depression Scale (MADRS)
•2\.5\. Patients who have the mental capacity to understand the trial and are able to give consent

•1\. Patients who are currently being or have been treated for depression and/or anxiety with any antidepressants in the last 3 months
•2\. Patients who are currently being or have been treated for depression and/or anxiety with a formal psychological therapy in the last 3 months
•3\. Patients who are awaiting a planned living donor transplant within the period of the trial
•4\. Patients who have less than 1 year survival prognosis according to the nephrologist
•5\. Patients for whom Sertraline is contraindicated by their existing drug regimen according to the Summary of Product Characteristics
•6\. Patients with hepatic impairment, whose serum level of alanine transaminase (ALT) is two times the upper limits of normal or higher
•7\. Patients who have hepatitis B or hepatitis C, HIV/AIDS, and/or Creutzfeldt\-Jakob disease
•8\. Patients who are pregnant or of childbearing potential who are not using adequate contaception
•9\. Patients who are or have been involved in an intervention study in the last 3 months
•10\. Patients with impaired coagulation judged by an international normalised ratio (INR) greater than 1\.3