About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Escitalopram 10mg
DrugEscitalopram tablet
Placebo
DrugSugar pill manufactured to mimic escitalopram 10 mg tablet
Computer-delivered naming treatment
Behavioral15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
Treatment groups
Trial outcomes
Primary outcomes
Change in Philadelphia Naming Test short-form accuracy score
Number of correctly named items of 30 total items on the computerized picture naming assessment. Scores ranges from 0 to 30 with higher scores meaning better naming ability.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
University of South Carolina
Collaborator
Medical University of South Carolina
Collaborator
University of California, Irvine
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator