NCT03843463 Escitalopram and Language Intervention for Subacute Aphasia
| NCT ID | NCT03843463 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Aphasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2021-07-18 |
| Primary Completion | 2026-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 88 participants in total. It began in 2021-07-18 with a primary completion date of 2026-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 untrained pictures and describing pictures, in individuals with aphasia in the acute and subacute post stroke period (i.e., within three months post stroke).
Eligibility 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.
Contact & Investigator
Argye Hillis-Trupe, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT03843463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Aphasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03843463 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03843463 currently recruiting?
Yes, NCT03843463 is actively recruiting participants. Contact the research team at argye@jhmi.edu for enrollment information.
Where is the NCT03843463 trial being conducted?
This trial is being conducted at Baltimore, United States, Charleston, United States, Columbia, United States.
Who is sponsoring the NCT03843463 clinical trial?
NCT03843463 is sponsored by Johns Hopkins University. The principal investigator is Argye Hillis-Trupe, MD at Johns Hopkins University. The trial plans to enroll 88 participants.