Recruiting
Phase 2

Escitalopram & Language Intervention

Sponsor:

Johns Hopkins University

Code:

NCT03843463

Conditions

Aphasia

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Escitalopram 10mg

Placebo

Computer-delivered naming treatment

Study Details

Brief summary:

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).

Conditions

Aphasia

Stroke

Study ID

NCT03843463

Start date

Jul 18, 2021

Status verified date

Sep, 2026

Completion date

Jun 18, 2027

Anticipated

Primary completion date

Feb 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Naming Treatment + Escitalopram

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)

placebo comparator: Naming Treatment + Placebo

10 mg placebo daily for three months

Interventions

Escitalopram 10mg

Escitalopram tablet

Placebo

Sugar pill manufactured to mimic escitalopram 10 mg tablet

Computer-delivered naming treatment

15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke

Primary outcome measure

  • Change in Philadelphia Naming Test short-form accuracy score [ Time Frame: Baseline, 1 week after computer-delivered naming treatment ]

Central Contacts and Locations

Central contacts

Argye Hillis-Trupe, MD

(410) 614-2381argye@jhmi.edu

Melissa D Stockbridge, PhD

md.stockbridge@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Argye E Hillis, MD

410-812-6716

Catherine Kelly, MA

410-502-6045chead2@jhu.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Leo Bonilha

843-792-5044bonilha@musc.edu

Kelly Krajeck

(843) 792-0189krajeck@musc.edu

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29208

Contacts

Souvik Sen

803-545-6073Souvik.Sen@uscmed.sc.edu

Leigh Ann Spell

(803) 777-2693spelll@mailbox.sc.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-03.