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Escitalopram and Language Intervention for Subacute Aphasia

Study acronym: ELISA
StatusRecruiting
PhasePhase 2
Started2021-07-18
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Sep 18, 2026 → Feb 18, 2027
See other at-risk trials from Johns Hopkins University

Amendment history

2026-09-02
Study Status v17
Primary completion pushed: 2026-09-18 → 2027-02-18
Completion pushed: 2027-01-18 → 2027-06-18
2025-09-18
Study Status v16
Primary completion date2025-09-18→2026-09-18
Completion date2026-01-18→2027-01-18
2024-11-08
Study Status v15
Re-verified, no change to tracked fields
2023-11-30
Study Identification, Study Status, Sponsor/Collaborators v14
Collaborators3 to 4 entries
National Institute on Deafness and Other Communication Disorders (NIDCD)
2023-04-11
Study Status, Arms and Interventions v13
Re-verified, no change to tracked fields
Show 12 earlier versions
2022-04-28
Study Status v12
Primary completion date2026-06-01→2025-09-18
Completion date2026-06-01→2026-01-18
2022-04-11
Completed→Recruiting Study Status, Study Design, Contacts/Locations v11
Trial statusCompleted→Recruiting
Primary completion date2022-04-01→2026-06-01
Completion date2022-04-01→2026-06-01
Enrollment target61→88
Study sitesdetails revised at 3 of 3 sites
2022-04-04
Recruiting→Completed Study Status, Study Design, Contacts/Locations v10
Trial statusRecruiting→Completed
Primary completion dateestimated 2024-07-18→confirmed 2022-04-01
Completion dateestimated 2024-07-18→confirmed 2022-04-01
Enrollment targetestimated 60→confirmed 61
Study sitesdetails revised at 3 of 3 sites
2021-09-02
Study Status, Outcome Measures, Eligibility, Contacts/Locations v9
Study sites1→3
Eligibility criteria+538 characters
[...] ts must be capable of giving informed consent or indicating anothera legally authorized representative to provide informed consent. Participants must be age 18 or older but not older than 99 years. 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 affectin [...] tric or neurological condition that affects naming/language A history of additional risk factors for to [...] [...]
Secondary endpoints9 to 13 entries
Post-strokeStroke qualityparesis of lifeseverity as assessed by Strokeright Impacthand Scale (SIS)strength Stroke paresis severity as assessed by right armhand strengthdexterity Change in new vocabulary items as assessed by lexical diversity included in 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 pr [...]
Primary endpoints1 entry, revised
Change in Philadelphia Naming Test short-form accuracy score
2021-07-21
Not Yet Recruiting→Recruiting Study Status, Oversight, Arms and Interventions, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-07→2024-07-18
Completion date2024-07→2024-07-18
Start dateestimated 2021-06→confirmed 2021-07-18
Study sitesdetails revised at 1 of 1 site
2021-06-07
Study Status v7
Start date2021-05→2021-06
2021-03-31
Study Status v6
Start date2021-03→2021-05
2020-09-30
Study Status v5
Start date2020-09→2021-03
2020-07-28
Study Status, Contacts/Locations v4
Re-verified, no change to tracked fields
2020-07-13
Study Status v3
Start date2020-07→2020-09
2020-02-10
Study Status v2
Primary completion date2024-02→2024-07
Completion date2024-02→2024-07
Start date2020-02→2020-07
2019-03-05
Study Status v1
Primary completion date2023-01→2024-02
Completion date2023-01→2024-02
Start date2019-02→2020-02
2019-02-14
Original filing
Johns Hopkins University
505 trials monitored
See 47 trials at risk
Stroke
3,268 trials monitored
See 122 trials at risk
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).
Trial Details
NCT Number NCT03843463
Lead Sponsor Johns Hopkins University
Collaborators: University of South Carolina, Medical University of South Carolina, University of California, Irvine, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions Aphasia, Stroke
Enrollment 88 participants
Start Date 2021-07-18
Primary Completion 2027-02-18 (estimated)
Study Completion 2027-06-18 (estimated)
Updated on ClinicalTrials.gov 2026-09-03