Post Stroke Emotionalism (PSE) Mental and Behavioural Disorders
Conditions
Interventions
Participants will be asked to take 2 x 25 mg oral sertraline tablets or 2 x matched placebo, once daily with or without food for 6 months.
After 6 months, or on discontinuation of treatment, particip
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 22/10/2025: 1. Age =18 years 2. Clinical diagnosis of acute stroke (all types) with imaging compatible with ischaemic or haemorrhagic stroke (including those with normal CT if clinical history strongly suggestive of stroke). 3. Any PSE sub-type (crying, laughter, combined) defined by CNS-LS score =13 4. Capacity, as assessed by the patient’s attending physician, to consent and complete trial assessments Previous key inclusion criteria: 1. Age =18 years 2. Clinical diagnosis of first or repeat acute stroke (all types) in past one year with imaging compatible with ischaemic or haemorrhagic stroke (including those with normal CT if clinical history strongly suggestive of stroke). 3. Any PSE sub-type (crying, laughter, combined) defined by CNS-LS score =13 4. Capacity, as assessed by the patient’s attending physician, to consent and complete trial assessments
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 22/10/2025: 1. Significant medical condition that in the opinion of the patient’s attending physician would affect subject safety or influence the study outcomes 2. Allergy to sertraline 3. Contraindication to Sertraline - known severe hepatic impairment, known long QT syndrome, close angle glaucoma, History of severe Chronic Kidney Disease (CKD) or severe 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) 4. Current or recent (within 1 month) treatment with any SSRI antidepressant or irreversible monoamine oxidase inhibitors (MAOIs) 5. 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 6. Current or known history of hyponatraemia 7. Enrolment in another CTIMP interventional study or not available for full follow-up duration 8. A known history of a drug overdose, self-harm or attempted suicide in the last three months 9. Pregnant or breastfeeding 10. Women of childbearing potential (WOCBP) and not using a highly effective form of contraception (see section 6.3 for full definitions) 11. 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 Previous exclusion criteria as of 05/08/2024: 1. Significant medical condition that in the opinion of the patient’s attending physician would affect subject safety or influence the study outcomes 2. Allergy to sertraline 3. 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) 4. Current or recent (within 1 month) treatment with any SSRI antidepressant or irreversible monoamine oxidase inhibitors (MAOIs) 5. 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 6. Current or known history of hyponatraemia 7. Enrolment in another CTIMP interventional study or not available for full follow-up duration 8. A known history of a drug overdose, self-harm or attempted suicide in the last three months 9. Pregnant or breastfeeding 10. Women of childbearing potential (WOCBP) and not using a highly effective form of contraception (see section 6.3 for full definitions) 11. 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 Previous exclusion criteria: 1. Significant medical condition that in the opinion of the patient’s attending physician would affect subject safety or influence the study outcomes 2. Allergy to sertraline 3. Contraindication to sertraline - including 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 s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between sertraline and placebo groups in the change of symptoms of Post Stroke Emotionalism (PSE), measured by CNS-LS between baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms of post-stroke emotionalism (PSE) measured using the Center for Neurologic Study-Lability Scale (CNS-LS) at 3 and 12 months post-randomisation (baseline and 6 months as primary outcome) 2. Symptoms of post-stroke emotionalism (PSE) measured using the Testing for Emotionalism After Recent Stroke-Questionnaire Crying-Questionnaire Crying (TEARS-Q) at baseline, 3, 6 and 12 months post-randomisation 3. Depression is measured using Patient Health Questionnaire – 9 (PHQ-9) at baseline, 3, 6 and 12 months post-randomisation 4. Anxiety is measured using the General Anxiety Disorder Scale (2 questions) (GAD-2) at baseline, 3, 6 and 12 months post-randomisation 5. Cognitive functioning, activities of daily living, social functioning and impact on relationships is measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) at baseline, 3, 6 and 12 months post-randomisation 6. Health-related quality of life is measured using the EuroQol Group EQ-5D-5L at baseline, 3, 6 and 12 months post-randomisation 7. Wellbeing is measured using the ICEpop CAPability measure for Older people (ICECAP-O) at baseline, 6 and 12 months post-randomisation 8. Acceptability of intervention is measured using an acceptability of intervention questionnaire at 6 months post-randomisation 9. Cost-effectiveness will be determined over 12 months from the perspective of the NHS and social care, with resource use data being collected via a modified Client Service Receipt Inventory (CSRI) at baseline, 6 and 12 months post-randomisation 10. Safety (serious adverse reactions) measured throughout, specifically at 2 weeks, 3, 6, 7 and 12 months post-randomisation 11. IMP adherence will be measured by a tablet count at 2 weeks and then at the end of each treatment period at 3, 6 and 7 months post-randomisation | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactVeronica Bion
Outcome results
None listed