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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.
Must not have
Previous neurological disease affecting the brain including previous symptomatic stroke
Diagnosis of schizophrenia, autism, or other psychiatric or neurological condition that affects naming/language
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week after computer-delivered naming treatment

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a brain condition or stroke with symptoms.
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I have a condition like schizophrenia or autism that affects my speech or language.
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I do not have severe depression (PHQ-9 score ≤ 15).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week after computer-delivered naming treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week after computer-delivered naming treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Philadelphia Naming Test short-form accuracy score
Secondary study objectives
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 more

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
2,339 Previous Clinical Trials
14,881,585 Total Patients Enrolled
14 Trials studying Aphasia
1,196 Patients Enrolled for Aphasia
University of California, IrvineOTHER
566 Previous Clinical Trials
1,932,960 Total Patients Enrolled
Medical University of South CarolinaOTHER
979 Previous Clinical Trials
7,400,877 Total Patients Enrolled
5 Trials studying Aphasia
339 Patients Enrolled for Aphasia
University of South CarolinaOTHER
223 Previous Clinical Trials
119,122 Total Patients Enrolled
6 Trials studying Aphasia
533 Patients Enrolled for Aphasia
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
181,970 Total Patients Enrolled
39 Trials studying Aphasia
2,736 Patients Enrolled for Aphasia
Argye Hillis-Trupe, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Escitalopram 10mg Clinical Trial Eligibility Overview. Trial Name: NCT03843463 — Phase 2
Aphasia Research Study Groups: Naming Treatment + Escitalopram, Naming Treatment + Placebo
Aphasia Clinical Trial 2023: Escitalopram 10mg Highlights & Side Effects. Trial Name: NCT03843463 — Phase 2
Escitalopram 10mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT03843463 — Phase 2
~14 spots leftby Sep 2025
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