EASE: Evaluating Antidepressants for Emotionalism after Stroke
Research type
Research Study
Full title
EASE: Evaluating Antidepressants for emotionaliSm after strokE: 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
IRAS ID
1008638
Contact name
Niall Broomfield
Contact email
Sponsor organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN67104246
Research summary
One in five people with stroke will have some degree of emotionalism by 6 months. Having emotionalism means you cry or laugh without warning, often inappropriately & uncontrollably. Post Stroke Emotionalism (PSE) negatively affects people’s daily life, & finding treatment is a priority for them.
This research aims to see if PSE symptoms can be reduced by taking sertraline (an antidepressant drug) daily for 6 months. Based on the results, we will be able to recommend whether, or not, PSE patients should take sertraline.
Over 30 months, 310 adults with stroke in the previous year and PSE symptoms will be recruited from approximately 30 UK hospitals, self Referrals or GP Practices. Half of the participants will be given sertraline, and the other half ‘placebo’ (a pill that looks like the real medicine but contains no active ingredient). Participants will be allocated to the groups at random, neither they or their clinical team will know which group they are in. They will be asked to complete some questionnaires at the start of the trial and again at their follow up visits at 3, 6 and 12 months. People’s answers to the questions will assess any changes the medication has made to symptoms of PSE and their quality of life.
People taking medicines that interact with sertraline, current or recent (within 14 days), and enrolled in another medication trial, pregnant, breast-feeding or of childbearing potential and not using contraception will not be able to take part. A few other detailed exclusion criteria related to medical history apply and a study doctor will explain these to potential participants.
The trial will be undertaken by doctors & researchers with experience of stroke & PSE. We will publicise the results by writing to the participants, reports for medical publications, media articles & social media. The trial is funded by the National Institute for Health & Care Research & sponsored by Norfolk & Norwich University Hospital NHS Trust.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0074
Date of REC Opinion
17 May 2024
REC opinion
Further Information Favourable Opinion