AphasiaPhase 2ELISANCT03843463
Escitalopram and Language Intervention for Subacute Aphasia
A Phase 2 study testing Escitalopram 10mg and Computer-delivered naming treatment in people with Aphasia and Stroke, run by Johns Hopkins University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- Escitalopram 10mg and Computer-delivered naming treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jul 2021to 18 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Melissa D Stockbridge, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Argye E Hillis, MD, 410-812-6716
Catherine Kelly, MA, 410-502-6045, chead2@jhu.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Leo Bonilha, 843-792-5044, bonilha@musc.edu
Kelly Krajeck, (843) 792-0189, krajeck@musc.edu
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Souvik Sen, 803-545-6073, Souvik.Sen@uscmed.sc.edu
Leigh Ann Spell, (803) 777-2693, spelll@mailbox.sc.edu
About this study
Official title: Escitalopram and Language Intervention for Subacute Aphasia (ELISA)
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).
Read the detailed description
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). There has been no previous randomized controlled trial (RCT) to evaluate the effect of daily SSRI in the first three months after stroke on improvement of language in people undergoing aphasia treatment. It is plausible that SSRIs, which elevate synaptic serotonin, might enhance recovery by augmenting synaptic plasticity.
The investigators propose to conduct a Phase 2 multi-center, randomized, double blind, placebo-controlled trial of escitalopram for augmenting language intervention in subacute stroke. The investigators hypothesize that daily escitalopram for 90 days after stroke results in greater improvement (compared to placebo) in naming untrained pictures, as well as greater increase in content of picture description and greater improvement in morphosyntactic production, when combined with speech and language treatment (SALT). A second aim is to evaluate the mechanisms of language recovery in individuals who receive active medical treatment and those who receive placebo, using resting state functional magnetic resonance imaging (rsfMRI) and genetic testing. The investigators hypothesize that greater improvement in language is associated with increased connectivity within the left hemisphere language network on rsfMRI in participants who receive escitalopram than in those who receive placebo, independently of improvement in depression. The investigators also hypothesize that the effects are greatest in individuals with val/val allele of brain-derived neurotrophic factor (BDNF) - (consistent with previous studies showing a greater response to treatment and greater neuroplasticity in people with the val/val allele than those with one or more met alleles.
- Being tested
- Escitalopram 10mg, Placebo, Computer-delivered naming treatment
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram 10mgDrug
Also called Lexapro
Escitalopram tablet
PlaceboDrug
Also called Placebo (for Escitalopram)
Sugar pill manufactured to mimic escitalopram 10 mg tablet
Computer-delivered naming treatmentBehavioural
Also called Computer-delivered naming treatment (CoDeNT)
15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
| Study group | Role | What they receive |
|---|---|---|
| Naming Treatment + Escitalopram | Experimental | 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) Receives: Drug: Escitalopram 10mg; Behavioral: Computer-delivered naming treatment |
| Naming Treatment + Placebo | Placebo comparator | 10 mg placebo daily for three months Receives: Drug: Placebo; Behavioral: Computer-delivered naming treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week after computer-delivered naming treatment
Secondary outcomes (13)
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.
Measured: Baseline, 5 weeks after computer-delivered naming treatment
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.
Measured: Baseline, 5 weeks after computer-delivered naming treatment
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.
Measured: Baseline, 5 weeks after computer-delivered naming treatment
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.
Measured: Baseline, 1 week after computer-delivered naming treatment
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.
Measured: Baseline, 1 week after computer-delivered naming treatment
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.
Measured: Baseline, 5 weeks after computer-delivered naming treatment, 20 weeks after computer-delivered naming treatment
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.
Measured: Baseline, 1 week after computer-delivered naming treatment
Stroke paresis severity as assessed by right hand strength
Right hand strength assessment by dynamometer
Measured: Baseline, 1 week after computer-delivered naming treatment
Stroke paresis severity as assessed by right hand dexterity
Right hand dexterity assessment by 9 peg board test
Measured: Baseline, 1 week after computer-delivered naming treatment
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.
Measured: Baseline, 1 week after computer-delivered naming treatment
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.
Measured: Baseline, 1 week after computer-delivered naming treatment
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
Measured: Baseline, 1 week after computer-delivered naming treatment
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
Measured: Baseline, 1 week after computer-delivered naming treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start18 Jul 2021
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, Medical University of South Carolina, University of California, Irvine, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Argye Hillis-Trupe, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843463
- Sponsor's protocol ID
- IRB00268564
- Other IDs
- P50DC014664
- Acronym
- ELISA
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2019
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.
PubMed 12649521Brady MC, Kelly H, Godwin J, Enderby P, Campbell P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2016 Jun 1;2016(6):CD000425. doi: 10.1002/14651858.CD000425.pub4.
PubMed 27245310Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.
PubMed 21216670FOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Lancet. 2019 Jan 19;393(10168):265-274. doi: 10.1016/S0140-6736(18)32823-X. Epub 2018 Dec 5.
PubMed 30528472Doron R, Lotan D, Versano Z, Benatav L, Franko M, Armoza S, Kately N, Rehavi M. Escitalopram or novel herbal mixture treatments during or following exposure to stress reduce anxiety-like behavior through corticosterone and BDNF modifications. PLoS One. 2014 Apr 1;9(4):e91455. doi: 10.1371/journal.pone.0091455. eCollection 2014.
PubMed 24690945Enderby P, Broeckx J, Hospers W, Schildermans F, Deberdt W. Effect of piracetam on recovery and rehabilitation after stroke: a double-blind, placebo-controlled study. Clin Neuropharmacol. 1994 Aug;17(4):320-31. doi: 10.1097/00002826-199408000-00003.
PubMed 9316679Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18.
PubMed 30150003Gu SC, Wang CD. Early Selective Serotonin Reuptake Inhibitors for Recovery after Stroke: A Meta-Analysis and Trial Sequential Analysis. J Stroke Cerebrovasc Dis. 2018 May;27(5):1178-1189. doi: 10.1016/j.jstrokecerebrovasdis.2017.11.031. Epub 2017 Dec 21.
PubMed 29276014Hayasaka Y, Purgato M, Magni LR, Ogawa Y, Takeshima N, Cipriani A, Barbui C, Leucht S, Furukawa TA. Dose equivalents of antidepressants: Evidence-based recommendations from randomized controlled trials. J Affect Disord. 2015 Jul 15;180:179-84. doi: 10.1016/j.jad.2015.03.021. Epub 2015 Mar 31.
PubMed 25911132Hillis AE. The 'standard' for poststroke aphasia recovery. Stroke. 2010 Jul;41(7):1316-7. doi: 10.1161/STROKEAHA.110.585364. Epub 2010 Jun 10. No abstract available.
PubMed 20538691Hillis AE, Beh YY, Sebastian R, Breining B, Tippett DC, Wright A, Saxena S, Rorden C, Bonilha L, Basilakos A, Yourganov G, Fridriksson J. Predicting recovery in acute poststroke aphasia. Ann Neurol. 2018 Mar;83(3):612-622. doi: 10.1002/ana.25184. Epub 2018 Mar 10.
PubMed 29451321Hillis AE, Tippett DC. Stroke Recovery: Surprising Influences and Residual Consequences. Adv Med. 2014;2014:378263. doi: 10.1155/2014/378263.
PubMed 25844378Huber W, Willmes K, Poeck K, Van Vleymen B, Deberdt W. Piracetam as an adjuvant to language therapy for aphasia: a randomized double-blind placebo-controlled pilot study. Arch Phys Med Rehabil. 1997 Mar;78(3):245-50. doi: 10.1016/s0003-9993(97)90028-9.
PubMed 9084344Jorge RE, Acion L, Moser D, Adams HP Jr, Robinson RG. Escitalopram and enhancement of cognitive recovery following stroke. Arch Gen Psychiatry. 2010 Feb;67(2):187-96. doi: 10.1001/archgenpsychiatry.2009.185.
PubMed 20124118Kraglund KL, Mortensen JK, Damsbo AG, Modrau B, Simonsen SA, Iversen HK, Madsen M, Grove EL, Johnsen SP, Andersen G. Neuroregeneration and Vascular Protection by Citalopram in Acute Ischemic Stroke (TALOS). Stroke. 2018 Nov;49(11):2568-2576. doi: 10.1161/STROKEAHA.117.020067.
PubMed 30355209
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram and Language Intervention for Subacute Aphasia (ELISA)
- ClinicalTrials.gov ID
- NCT03843463
- Acronym / sponsor ID
- ELISA / IRB00268564
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of South Carolina, Medical University of South Carolina, University of California, Irvine, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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). There has been no previous randomized controlled trial (RCT) to evaluate the effect of daily SSRI in the first three months after stroke on improvement of language in people undergoing aphasia treatment. It is plausible that SSRIs, which elevate synaptic serotonin, might enhance recovery by augmenting synaptic plasticity.
The investigators propose to conduct a Phase 2 multi-center, randomized, double blind, placebo-controlled trial of escitalopram for augmenting language intervention in subacute stroke. The investigators hypothesize that daily escitalopram for 90 days after stroke results in greater improvement (compared to placebo) in naming untrained pictures, as well as greater increase in content of picture description and greater improvement in morphosyntactic production, when combined with speech and language treatment (SALT). A second aim is to evaluate the mechanisms of language recovery in individuals who receive active medical treatment and those who receive placebo, using resting state functional magnetic resonance imaging (rsfMRI) and genetic testing. The investigators hypothesize that greater improvement in language is associated with increased connectivity within the left hemisphere language network on rsfMRI in participants who receive escitalopram than in those who receive placebo, independently of improvement in depression. The investigators also hypothesize that the effects are greatest in individuals with val/val allele of brain-derived neurotrophic factor (BDNF) - (consistent with previous studies showing a greater response to treatment and greater neuroplasticity in people with the val/val allele than those with one or more met alleles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naming Treatment + Escitalopram | Experimental | Drug: Escitalopram 10mg, Behavioral: Computer-delivered naming treatment10 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) |
| Naming Treatment + Placebo | Placebo comparator | Drug: Placebo, Behavioral: Computer-delivered naming treatment10 mg placebo daily for three months |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram 10mgAlso: LexaproEscitalopram tablet | Drug | Naming Treatment + Escitalopram |
| PlaceboAlso: Placebo (for Escitalopram)Sugar pill manufactured to mimic escitalopram 10 mg tablet | Drug | Naming Treatment + Placebo |
| Computer-delivered naming treatmentAlso: Computer-delivered naming treatment (CoDeNT)15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke | Behavioural | Naming Treatment + Escitalopram, Naming Treatment + Placebo |
Primary outcome
Change in Philadelphia Naming Test short-form accuracy score
Time frame: Baseline, 1 week after computer-delivered naming treatment
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.
13 secondary outcomes
Language production as assessed by lexical features of discourse in "Cookie Theft" picture description
Time frame: Baseline, 5 weeks after computer-delivered naming treatment
Language production as assessed by content units included in picture description of "Cookie Theft"
Time frame: Baseline, 5 weeks after computer-delivered naming treatment
Language production as assessed by rate of syllables per content unit produced in "Cookie Theft" picture description
Time frame: Baseline, 5 weeks after computer-delivered naming treatment
Depression as assessed by Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 1 week after computer-delivered naming treatment
Language production as assessed by Morphosyntactic Generation (MorGen) Test
Time frame: Baseline, 1 week after computer-delivered naming treatment
Stroke severity as assessed by NIH Stroke Scale (NIHSS)
Time frame: Baseline, 5 weeks after computer-delivered naming treatment, 20 weeks after computer-delivered naming treatment
Post-stroke level of disability as assessed by modified Rankin Scale (mRS)
Time frame: Baseline, 1 week after computer-delivered naming treatment
Stroke paresis severity as assessed by right hand strength
Time frame: Baseline, 1 week after computer-delivered naming treatment
Stroke paresis severity as assessed by right hand dexterity
Time frame: Baseline, 1 week after computer-delivered naming treatment
Change in new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella"
Time frame: Baseline, 1 week after computer-delivered naming treatment
Change in incidence of new vocabulary items as assessed by lexical diversity included in story retelling of "Cinderella"
Time frame: Baseline, 1 week after computer-delivered naming treatment
Change in language production as assessed by speech errors produced during the story retelling of "Cinderella"
Time frame: Baseline, 1 week after computer-delivered naming treatment
Change in Language production as assessed by speech pauses produced during the story retelling of "Cinderella"
Time frame: Baseline, 1 week after computer-delivered naming treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 12649521Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.
- Background: PubMed 27245310Brady MC, Kelly H, Godwin J, Enderby P, Campbell P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2016 Jun 1;2016(6):CD000425. doi: 10.1002/14651858.CD000425.pub4.
- Background: PubMed 21216670Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.
- Background: PubMed 30528472FOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Lancet. 2019 Jan 19;393(10168):265-274. doi: 10.1016/S0140-6736(18)32823-X. Epub 2018 Dec 5.
- Background: PubMed 24690945Doron R, Lotan D, Versano Z, Benatav L, Franko M, Armoza S, Kately N, Rehavi M. Escitalopram or novel herbal mixture treatments during or following exposure to stress reduce anxiety-like behavior through corticosterone and BDNF modifications. PLoS One. 2014 Apr 1;9(4):e91455. doi: 10.1371/journal.pone.0091455. eCollection 2014.
- Background: PubMed 9316679Enderby P, Broeckx J, Hospers W, Schildermans F, Deberdt W. Effect of piracetam on recovery and rehabilitation after stroke: a double-blind, placebo-controlled study. Clin Neuropharmacol. 1994 Aug;17(4):320-31. doi: 10.1097/00002826-199408000-00003.
- Background: PubMed 30150003Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18.
- Background: PubMed 29276014Gu SC, Wang CD. Early Selective Serotonin Reuptake Inhibitors for Recovery after Stroke: A Meta-Analysis and Trial Sequential Analysis. J Stroke Cerebrovasc Dis. 2018 May;27(5):1178-1189. doi: 10.1016/j.jstrokecerebrovasdis.2017.11.031. Epub 2017 Dec 21.
- Background: PubMed 25911132Hayasaka Y, Purgato M, Magni LR, Ogawa Y, Takeshima N, Cipriani A, Barbui C, Leucht S, Furukawa TA. Dose equivalents of antidepressants: Evidence-based recommendations from randomized controlled trials. J Affect Disord. 2015 Jul 15;180:179-84. doi: 10.1016/j.jad.2015.03.021. Epub 2015 Mar 31.
- Background: PubMed 20538691Hillis AE. The 'standard' for poststroke aphasia recovery. Stroke. 2010 Jul;41(7):1316-7. doi: 10.1161/STROKEAHA.110.585364. Epub 2010 Jun 10. No abstract available.
- Background: PubMed 29451321Hillis AE, Beh YY, Sebastian R, Breining B, Tippett DC, Wright A, Saxena S, Rorden C, Bonilha L, Basilakos A, Yourganov G, Fridriksson J. Predicting recovery in acute poststroke aphasia. Ann Neurol. 2018 Mar;83(3):612-622. doi: 10.1002/ana.25184. Epub 2018 Mar 10.
- Background: PubMed 25844378Hillis AE, Tippett DC. Stroke Recovery: Surprising Influences and Residual Consequences. Adv Med. 2014;2014:378263. doi: 10.1155/2014/378263.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa D Stockbridge, PhD contact
Argye Hillis-Trupe, MD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Escitalopram 10mg and Computer-delivered naming treatment in people with Aphasia and Stroke, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Argye Hillis-Trupe, MD ((410) 614-2381, argye@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Philadelphia Naming Test short-form accuracy score (time frame: Baseline, 1 week after computer-delivered naming treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843463, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.