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Escitalopram + Language Therapy for Aphasia (ELISA Trial)
Phase 2
Recruiting
Led By Argye Hillis-Trupe, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week after computer-delivered naming treatment
Awards & highlights
ELISA Trial Summary
This trial will investigate whether the drug escitalopram can help improve language skills in people with aphasia who are receiving therapy, compared to those who are receiving therapy without the drug.
Who is the study for?
This trial is for right-handed, English-speaking adults who've had a left hemisphere ischemic stroke within the past 5 days and have been diagnosed with aphasia. They must be able to consent or have someone to do it for them. Excluded are those with prior brain diseases, severe visual/hearing loss, depression medication use at stroke onset, pregnancy, certain heart risks or psychiatric conditions affecting language.Check my eligibility
What is being tested?
The study tests if Escitalopram (an SSRI) can improve the effectiveness of computer-delivered naming therapy for people with aphasia after a recent stroke. Participants will either receive Escitalopram or a placebo alongside their language therapy sessions.See study design
What are the potential side effects?
Escitalopram may cause side effects like nausea, sleep disturbances, fatigue, dry mouth and increased sweating. It might also affect heart rhythm (QTc prolongation), which is why individuals with certain heart conditions are excluded from the trial.
ELISA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can make my own medical decisions or have someone who can.
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I am 18 years old or older.
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I had a stroke less than 5 days ago.
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I had a stroke affecting the left side of my brain.
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I have been diagnosed with aphasia.
ELISA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 week after computer-delivered naming treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week after computer-delivered naming treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Philadelphia Naming Test short-form accuracy score
Secondary outcome measures
Change in Language production as assessed by speech pauses produced during the story retelling of "Cinderella"
Change in incidence of new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella"
Change in language production as assessed by speech errors produced during the story retelling of "Cinderella"
+10 moreELISA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Naming Treatment + EscitalopramExperimental Treatment2 Interventions
10 mg escitalopram daily for three months (escalating from 5 mg per day for the first week and tapering to 5 mg per day for the last two weeks)
Group II: Naming Treatment + PlaceboPlacebo Group2 Interventions
10 mg placebo daily for three months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram 10mg
2022
Completed Phase 4
~160
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,275 Previous Clinical Trials
14,840,550 Total Patients Enrolled
13 Trials studying Aphasia
1,061 Patients Enrolled for Aphasia
University of California, IrvineOTHER
546 Previous Clinical Trials
1,923,113 Total Patients Enrolled
Medical University of South CarolinaOTHER
940 Previous Clinical Trials
7,396,906 Total Patients Enrolled
5 Trials studying Aphasia
339 Patients Enrolled for Aphasia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can make my own medical decisions or have someone who can.I am 18 years old or older.Your heart's electrical activity (measured by ECG) is too slow or you have low sodium levels in your blood at the beginning of the study.I had a stroke less than 5 days ago.I am not taking MAOIs, pimozide, drugs that affect heart rhythm, or specific migraine medications.I have always used my right hand for tasks before getting sick.You have uncorrected vision or hearing problems that you know about.I have had a brain condition or stroke with symptoms.I was taking FDA-approved depression medication when I had a stroke.I had a stroke affecting the left side of my brain.I have a condition like schizophrenia or autism that affects my speech or language.I have risk factors for a rare heart rhythm condition (like heart failure or low potassium).I do not have severe depression (PHQ-9 score ≤ 15).I have been diagnosed with aphasia.
Research Study Groups:
This trial has the following groups:- Group 1: Naming Treatment + Escitalopram
- Group 2: Naming Treatment + Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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