RECRUITING Phase 2 ClinicalTrials.gov

Escitalopram and Language Intervention for Subacute Aphasia

Sponsor: Johns Hopkins University • ClinicalTrials.gov ID: NCT03843463

Registry updated: 2026-09-03

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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 untrained pictures and describing pictures, in individuals with aphasia in the acute and subacute post stroke period (i.e., within three months post stroke).

Interventions

Escitalopram 10mg (Drug)
Escitalopram tablet
Placebo (Drug)
Sugar pill manufactured to mimic escitalopram 10 mg tablet
Computer-delivered naming treatment (Behavioral)
15 45-minute sessions of computer-delivered naming treatment beginning two months following 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.

Conditions

Aphasia Stroke

Locations

Johns Hopkins School of Medicine — Baltimore, Maryland, United States
Medical University of South Carolina — Charleston, South Carolina, United States
University of South Carolina — Columbia, South Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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