RECRUITING

Escitalopram and Language Intervention for Subacute Aphasia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Escitalopram and Language Intervention for Subacute Aphasia (ELISA)

Quick Facts

Study Start:2021-07-18

Study Completion:2026-01-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03843463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Argye Hillis-Trupe, MD

CONTACT

(410) 614-2381

argye@jhmi.edu

Melissa D Stockbridge, PhD

CONTACT

md.stockbridge@jhmi.edu

Principal Investigator

Argye Hillis-Trupe, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

University of South Carolina

Columbia, South Carolina, 29208

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Argye Hillis-Trupe, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-18

Study Completion Date2026-01-18

Study Record Updates

Study Start Date2021-07-18

Study Completion Date2026-01-18

Terms related to this study

Additional Relevant MeSH Terms

Aphasia
Stroke