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Escitalopram and Language Intervention for Subacute Aphasia (ELISA)
NCT03843463Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2021
- Primary completion
- Feb 2027
- Countries
- 1
- Sponsor
- Johns Hopkins University
- Modality
- Small Molecules
- Conditions
- aphasia
01
Overview
Phase 2, randomised, double-blind trial of Escitalopram oxalate oral solution in aphasia (2 arms), sponsored by Johns Hopkins University. Primary endpoint: Philadelphia Naming Test short-form accuracy score. Started Jul 2021; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Naming Treatment + Escitalopram
10 mg escitalopram daily for three months + 15 sessions of computer-delivered naming treatment
Naming Treatment + Placebo
10 mg placebo daily for three months + 15 sessions of computer-delivered naming treatment
03
Who it enrols
Adults with acute ischemic left hemisphere stroke and aphasia, within 5 days of stroke onset, excluding those with severe depression, prior neurological diseases, or taking contraindicated medications.
04
Endpoints
Primary
Philadelphia Naming Test short-form accuracy score
Secondary
Lexical features of discourse in Cookie Theft picture description
Content units included in picture description of Cookie Theft
Rate of syllables per content unit produced in Cookie Theft picture description
Patient Health Questionnaire-9
Morphosyntactic Generation Test
NIH Stroke Scale
modified Rankin Scale
Right hand strength
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