Status:
RECRUITING
Escitalopram and Language Intervention for Subacute Aphasia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
University of South Carolina
Medical University of South Carolina
Conditions:
Aphasia
Stroke
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
In this project, the investigators will investigate the effects of a selective serotonin reuptake inhibitor (SSRI), escitalopram, on augmenting language therapy effectiveness, as measured by naming un...
Detailed Description
In this project, the investigators will investigate the effects of a selective serotonin reuptake inhibitor (SSRI), escitalopram, on augmenting language therapy effectiveness, as measured by naming un...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 18 2027
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03843463
Start Date
July 18 2021
End Date
January 18 2027
Last Update
September 23 2025
Active Locations (3)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
3
University of South Carolina
Columbia, South Carolina, United States, 29208