ISRCTN67104246Active, not recruitingPhase 3
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 6 months) in people with a recent stroke and post-stroke emotionalism
orfolk and Norwich University Hospitals NHS Foundation Trust0 sites310 target enrollmentStarted: August 2, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 310
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •Current 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 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. Enrolment in another CTIMP interventional study or not available for full follow-up duration
- •7. A known history of a drug overdose, self-harm or attempted suicide in the last three months
- •8. Pregnant, breastfeeding or of childbearing age and not using contraception
- •9. 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
Investigators
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