Table 1. World Health Organization Trial Registration Data Set.

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov NCT03843463
Date of registration in primary registry	February 18, 2019
Secondary identifying numbers	IRB00203667
Source(s) of monetary or material support	National Institute on Deafness and Other Communication Disorders (NIH/NIDCD) P50 DC011739
	Note: This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Primary sponsor	Johns Hopkins University
Secondary sponsor(s)	None
Contact for public queries	Argye Hillis-Trupe, MD (410) 614–2381 argye@jhmi.edu
Contact for scientific queries	Argye Hillis-Trupe, MD (410) 614–2381 argye@jhmi.edu
Public title	Escitalopram and Language Intervention for Subacute Aphasia (ELISA)
Scientific title	Escitalopram and Language Intervention for Subacute Aphasia (ELISA)
Countries of recruitment	United States of America
Health condition(s) or problem(s) studied	Aphasia, Stroke
Intervention(s)	• Drug: Escitalopram 10mg Escitalopram tablet Other Name: Lexapro • Drug: Placebo Sugar pill manufactured to mimic escitalopram 10 mg tablet Other Name: Placebo (for Escitalopram) • Behavioral: Computer-delivered naming treatment 15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke Other Name: CoDeNT (Computer-delivered naming treatment)
Key inclusion and exclusion criteria	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 type	Interventional
	Allocation: Randomized
	Intervention model: Parallel Assignment
	Masking: Triple (Participant, Care Provider, Investigator
	Primary purpose: Treatment
	Phase II
Date of first enrollment	July 18, 2021
Target sample size	60
Recruitment status	Recruiting
Primary outcome(s)	Change in Philadelphia Naming Test short form accuracy score [ Time Frame: Baseline, 1 week after computer-delivered naming treatment ]
Key secondary outcomes	2. Language production as assessed by lexical features of discourse in "Cookie Theft" picture description Lexical features, meaning carrying units of language (morphemes), will be counted for each Cookie Theft picture description. There is no maximum number of meaning carrying units, but norms are available to assist in the interpretation of this performance. [Time Frame: Baseline, 5 weeks after computer-delivered naming treatment] 3. Language production as assessed by content units included in picture description of "Cookie Theft" Content units are based on a standard scoring template of commonly identified concepts (nouns and verbs) in the left and right regions of the "Cookie Theft" picture. Participants either include or fail to include 30 concepts on the left side of the picture and 23 concepts on the right side of the picture. A ratio of included left content units to included right content units then can be calculated and interpreted as a measure of hemispatial attention. [Time Frame: Baseline, 5 weeks after computer-delivered naming treatment] 4. Language production as assessed by rate of syllables per content unit produced in "Cookie Theft" picture description Syllables included in the picture description are counted. Content units are based on a standard scoring template of commonly identified concepts (nouns and verbs) in the left and right regions of the "Cookie Theft" picture. Participants either include or fail to include 30 concepts on the left side of the picture and 23 concepts on the right side of the picture. The average rate of syllables per content unit produced can then be calculated and interpreted as a measure of efficiency in producing relevant information in the task. [Time Frame: Baseline, 5 weeks after computer-delivered naming treatment] 5. Depression as assessed by Patient Health Questionnaire (PHQ-9) 9 item scale scored 0–3 for each item. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression. PHQ-9 >15 or suicidal ideation suggest depression sufficient for exclusion or removal from study. [Time Frame: Baseline, 1 week after computer-delivered naming treatment] 6. Language production as assessed by Morphosyntactic Generation (MorGen) Test 60 item assessment of word morphology (e.g., plurals, possessives) and modifiers (e.g., number, size, color). Each item is scored based on produced accurate descriptors of an image relative to a second reference image (e.g., patients see two trees, one larger than the other, and the phrase "little tree" is elicited). Patients are scored for objects correctly named (nouns) out of 60, instances of correct use of plural marker out of 31, instances of correct use of numbers out of 8, instances of correct modifiers denoting size out of 16, instances of correct modifiers denoting color out of 19, instances of correct modifiers denoting possessive markers out of 17, and instances of correctly named possessing individuals (proper names provided on screen) out of 17. These scores can then be interpreted separately or averaged to interpret a broad morphosyntactic accuracy score. [Time Frame: Baseline, 1 week after computer-delivered naming treatment] 7. Stroke severity as assessed by NIH Stroke Scale (NIHSS) The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. [Time Frame: Baseline, during computer-delivered naming treatment, 5 weeks after computer-delivered naming treatment, 20 weeks after computer-delivered naming treatment] 8. Post-stroke level of disability as assessed by modified Rankin Scale (mRS) The mRS is a 6-level scale from "0-No symptoms" to "6-dead" used to evaluate the degree of disability in patients who have suffered a stroke. [Time Frame: Baseline, 1 week after computer-delivered naming treatment] 9. Stroke paresis severity as assessed by right hand strength Right hand strength assessment by dynamometer [Time Frame: Baseline, 1 week after computer-delivered naming treatment] 10. Stroke paresis severity as assessed by right hand dexterity Right hand dexterity assessment by 9 peg board test [Time Frame: Baseline, 1 week after computer-delivered naming treatment] 11. Change in new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella" Change in new vocabulary items will be counted for each noun, verb, and adjective in the Cinderella retelling. There is no maximum measure of lexical diversity, but norms are available to assist in the interpretation of this performance. [Time Frame: Baseline, 1 week after computer-delivered naming treatment] 12. Change in incidence of new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella" Change in incidence of each new item will be counted for each noun, verb, and adjective in the Cinderella retelling. There is no maximum measure of lexical diversity, but norms are available to assist in the interpretation of this performance. [Time Frame: Baseline, 1 week after computer-delivered naming treatment] 13. Change in language production as assessed by speech errors produced during the story retelling of "Cinderella" Change in number of errors will be counted after each retelling is recorded [Time Frame: Baseline, 1 week after computer-delivered naming treatment] 14. Change in Language production as assessed by speech pauses produced during the story retelling of "Cinderella" Change in pauses will be counted after each retelling is recorded [Time Frame: Baseline, 1 week after computer-delivered naming treatment]