Using escitalopram to enhance language therapy for stroke patients with aphasia
Escitalopram and Language Intervention for Subacute Aphasia (ELISA)
This study is testing if taking escitalopram can help stroke patients with aphasia improve their language skills better when combined with speech therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT03843463 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of escitalopram, a selective serotonin reuptake inhibitor (SSRI), on improving language therapy outcomes in individuals with aphasia following a stroke. The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial that aims to determine if daily escitalopram for 90 days can enhance language recovery when combined with speech and language treatment. Participants will be assessed on their ability to name untrained pictures and describe images, with additional evaluations using functional MRI and genetic testing to understand the mechanisms of recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who have experienced an acute ischemic left hemisphere stroke and have a confirmed diagnosis of aphasia.
Not a fit: Patients with previous neurological diseases, severe psychiatric conditions, or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve language recovery in stroke patients with aphasia.
How similar studies have performed: While this specific approach has not been previously tested, the use of SSRIs in enhancing recovery after stroke has shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have sustained an acute ischemic left hemisphere stroke. * Participants must be fluent speakers of English by self-report. * Participants must be capable of giving informed consent or indicating a legally authorized representative to provide informed consent. * Participants must be age 18 or older. * Participants must be within 5 days of onset of stroke. * Participants must be pre-morbidly right-handed by self-report. * Participants must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised (Aphasia Quotient \< 93.8). Exclusion Criteria: * Previous neurological disease affecting the brain including previous symptomatic stroke * Diagnosis of schizophrenia, autism, or other psychiatric or neurological condition that affects naming/language * A history of additional risk factors for torsades de pointes (TdP; e.g., heart failure, hypokalemia, family history of Long QT Syndrome) * Current severe depression, defined as a score of \> 15 on the Patient Health Questionnaire (PHQ-9) * Uncorrected visual loss or hearing loss by self-report * Use of any medication approved by the FDA for treatment of depression at the time of stroke onset * Concomitant use of any monoamine oxidase inhibitors (MAOIs) or pimozide, or other drugs that prolong the QT/QTc interval, triptans (and other 5-Hydroxytryptamine Receptor Agonists), or other contraindications to escitalopram that may be identified. * A QTc greater than 450 milliseconds on electrocardiogram or evidence of hyponatremia (Na \< 130) at baseline * Pregnancy at the time of stroke or planning to become pregnant during the study term.
Where this trial is running
Baltimore, Maryland and 2 other locations
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- University of South Carolina — Columbia, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Argye Hillis-Trupe, MD — Johns Hopkins University
- Study coordinator: Argye Hillis-Trupe, MD
- Email: argye@jhmi.edu
- Phone: (410) 614-2381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.