Using escitalopram to enhance language therapy for stroke patients with aphasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tailoring rTMS for Post-Stroke Aphasia Based on Language Profile

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• tDCS in Rehab for Stroke-Related Aphasia: A Practical Implementation

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• Digital speech-therapy app Zenicom for subacute post-stroke aphasia in Korean speakers

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• Deep phenotyping to explore recovery in young adults after stroke

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  Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

• TMS plus language therapy to improve word-finding after left-hemisphere stroke

  Researchers will try excitatory transcranial magnetic stimulation combined with semantic feature analysis language therapy to improve word-finding in adults with aphasia after left-hemisphere stroke.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.