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New treatment option for Aphasia
Official title Escitalopram and Language Intervention for Subacute Aphasia
ClinicalTrials.gov ID: NCT03843463
What this study is testing
What is Escitalopram 10mg?
Escitalopram 10mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for aphasia.
Also referred to as Lexapro.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Charleston, South Carolina, United States
- Columbia, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Charleston, South Carolina, United States; Columbia, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.