Scientific Title:

A multi-centre, randomised, double-blind, placebo-controlled trial to establish the effect(s) of administration of sertraline (50 mg once daily for Six Months) in people with a recent stroke and post-stroke emotionalism

Lead Investigator:

Professor Niall Broomfield (Professor of Clinical Psychology)

Clinical Chief Investigator:

Dr Kneale Metcalf (Consultant Stroke Physician at Norfolk and Norwich University Hospital)

Co-Applicants:

Professor Lee Shepstone (Professor of Statistics at UEA)

Professor Martin Dennis (Professor of Stroke Medicine at the University of Edinburgh)

Professor Robert Howard (Professor of Old Age Psychiatry at University College London)

Professor Dame Caroline Leigh-Watkins (Professor of Stroke Nursing at University of Central Lancashire)

Professor Maree Hackett (Professor of Epidemiology at University of Central Lancashire)

Professor Robert West (Professor of Biostatistics at the University of Leeds)

Mr David Turner (Researcher in Health Economics at UEA)

Dr Helen Parretti (GP and a Researcher at UEA and leads PPIE for EASE with Jeremy)

Dr Joanna Semlyen (Researcher at UEA with an interest in equality, diversity, and inclusion)

Mr Jeremy Dearling (A member of the public with an interest in research)

Dr Terence Quinn (Researcher in Stroke at the University of Glasgow)

Dr Eirini Kontou (Researcher in Stroke at the University of Nottingham)

Dr Yvonne Chun (Researcher in Stroke at the University of Edinburgh)

Dr Naaheed Mukadam (Researcher at University College London helping with equality, diversity, and inclusion in the trial)

Mr Moise Roche (Researcher at University College London helping with equality, diversity, and inclusion in the trial)

Funder:

National Institute for Health and Care Research – HTA programme

Sponsor:

Norwich and Norwich University Hospitals NHS Foundation Trust

Health condition or Problem Studied:

Stroke and post-stroke Emotionalism

Intervention:

Patient will be randomised on a 1:1 basis to receive either of the following for 6 months:

• Active Arm: 50mg Sertraline, as 2 x 25mg tablets, taken once daily.

Or

• Control Arm: 50mg matched placebo, as 2 x 25mg tablets, taken once daily.

Study Design:

EASE is a Phase III, multi-centre, parallel-group, 1:1 securely randomised, double-blind, placebo-controlled clinical trial of an investigational medicinal product.

The investigational medicinal product is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI), licenced in the UK as an antidepressant. It will be used outside of its licenced indication for this trial.

Target Sample Size:

310 participants (155 per arm)

Status:

In set-up