EASE (CPMS 59291, IRAS 1008638)

UPDATED - 16/05/2025

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 & PSE symptoms will be recruited from approximately 30 UK hospitals,self referrals or GP Practices. Half of the participants will be given the trial medication,sertraline,and the other half a ‘placebo’ (a pill that looks like the real medicine but contains no active ingredient). Participants will also be asked to complete questionnaires before they are allocated to received either of the trial medications,again 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.

The trial will be undertaken by doctors & researchers with experience of stroke & PSE. We will publicise our results by writing 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.

INCLUSION CRITERIA:

• 18 years or older

• Clinical diagnosis of first or repeat acute stroke in past one year with imaging compatible with ischaemic or haemorrhagic stroke (including those with normal CT if clinical history strongly suggestive of stroke.)

• Any PSE sub-type (crying, laughter ,combined) defined by CNS-LS score ≥13

• Capacity, as assessed by the patient’s attending physician to consent and complete trial assessments

  EXCLUSION CRITERIA:

Significant medical condition that in the opinion of the patient’s attending physician would affect subject safety or influence the study outcomes Allergy to Sertraline   Contraindication to Sertraline - known hepatic impairment, known long QT syndrome, close angle glaucoma, History of Chronic Kidney Disease (CKD) or Chronic Obstruction Pulmonary Disease (COPD), using a medication that could interact seriously with Sertraline e.g. pimozide, monoamine oxidase inhibitors and other serotonergic drugs (amphetamines, triptans and fentanyl) Current or recent (within 1 month) treatment with any SSRI antidepressant or irreversible monoamine oxidase inhibitors (MAOIs) Recent (within 1 month) change in non-SSRI antidepressants. Those on a stable dose for 1 month or more will still be eligible, including those having psychological therapies for anxiety/depression Current or known history of hyponatraemia Enrolment in another CTIMP interventional study or not available for full follow-up duration a known history of a drug overdose, self-harm or attempted suicide in the last three months pregnant or breast-feeding Women of Childbearing Potential (WOCBP) and not using a highly effective form of contraception Unable or prefers not to undertake trial assessments remotely. Options to participate will include by post, telephone or video calls or completion of assessments online. 

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

EMIS: Jodie Button – jodie.button@nihr.ac.uk 

SystmOne: James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

While we endeavour to keep the information, tools and resources provided up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the tools provided for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of the tools provided.