Escitalopram and Language Intervention for Subacute Aphasia
NCT ID: NCT03843463
Last Updated: 2025-09-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
88 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-07-18
Study Completion Date
2027-01-18
Brief Summary
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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).
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Detailed Description
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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.
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.
Conditions
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Aphasia
Stroke
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Naming Treatment + Escitalopram
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)
Group Type
EXPERIMENTAL
Escitalopram 10mg
Intervention Type
DRUG
Escitalopram tablet
Computer-delivered naming treatment
Intervention Type
BEHAVIORAL
15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
Naming Treatment + Placebo
10 mg placebo daily for three months
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Sugar pill manufactured to mimic escitalopram 10 mg tablet
Computer-delivered naming treatment
Intervention Type
BEHAVIORAL
15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
Interventions
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Escitalopram 10mg
Escitalopram tablet
Intervention Type
DRUG
Placebo
Sugar pill manufactured to mimic escitalopram 10 mg tablet
Intervention Type
DRUG
Computer-delivered naming treatment
15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
Intervention Type
BEHAVIORAL
Other Intervention Names
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Lexapro
Placebo (for Escitalopram)
Computer-delivered naming treatment (CoDeNT)
Eligibility Criteria
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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).
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Johns Hopkins University
OTHER
Sponsor Role
lead
University of South Carolina
OTHER
Sponsor Role
collaborator
Medical University of South Carolina
OTHER
Sponsor Role
collaborator
University of California, Irvine
OTHER
Sponsor Role
collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Sponsor Role
collaborator
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Argye Hillis-Trupe, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Site Status
RECRUITING
Medical University of South Carolina
Charleston, South Carolina, United States
Site Status
RECRUITING
University of South Carolina
Columbia, South Carolina, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Argye E Hillis, MD
Role: primary
410-812-6716
References
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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.
Reference Type
BACKGROUND
Brady 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.
Reference Type
BACKGROUND
Chollet 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.
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BACKGROUND
FOCUS 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.
Reference Type
BACKGROUND
Doron 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.
Reference Type
BACKGROUND
Enderby 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.
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BACKGROUND
Fridriksson 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.
Reference Type
BACKGROUND
Gu 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.
Reference Type
BACKGROUND
Hayasaka 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.
Reference Type
BACKGROUND
Hillis 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.
Reference Type
BACKGROUND
Hillis 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.
Reference Type
BACKGROUND
Hillis AE, Tippett DC. Stroke Recovery: Surprising Influences and Residual Consequences. Adv Med. 2014;2014:378263. doi: 10.1155/2014/378263.
Reference Type
BACKGROUND
Huber 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.
Reference Type
BACKGROUND
Jorge 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.
Reference Type
BACKGROUND
Kraglund 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.
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BACKGROUND
Kurland J, Pulvermuller F, Silva N, Burke K, Andrianopoulos M. Constrained versus unconstrained intensive language therapy in two individuals with chronic, moderate-to-severe aphasia and apraxia of speech: behavioral and fMRI outcomes. Am J Speech Lang Pathol. 2012 May;21(2):S65-87. doi: 10.1044/1058-0360(2012/11-0113). Epub 2012 Jan 31.
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Lam RW. Antidepressants and QTc prolongation. J Psychiatry Neurosci. 2013 Mar;38(2):E5-6. doi: 10.1503/jpn.120256. No abstract available.
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BACKGROUND
Lazar RM, Minzer B, Antoniello D, Festa JR, Krakauer JW, Marshall RS. Improvement in aphasia scores after stroke is well predicted by initial severity. Stroke. 2010 Jul;41(7):1485-8. doi: 10.1161/STROKEAHA.109.577338. Epub 2010 Jun 10.
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BACKGROUND
Marangolo P, Fiori V, Sabatini U, De Pasquale G, Razzano C, Caltagirone C, Gili T. Bilateral Transcranial Direct Current Stimulation Language Treatment Enhances Functional Connectivity in the Left Hemisphere: Preliminary Data from Aphasia. J Cogn Neurosci. 2016 May;28(5):724-38. doi: 10.1162/jocn_a_00927. Epub 2016 Jan 25.
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BACKGROUND
Mead GE, Hsieh CF, Lee R, Kutlubaev MA, Claxton A, Hankey GJ, Hackett ML. Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD009286. doi: 10.1002/14651858.CD009286.pub2.
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BACKGROUND
Pan XL, Chen HF, Cheng X, Hu CC, Wang JW, Fu YM, Kong HM, Shao HJ. Effects of Paroxetine on Motor and Cognitive Function Recovery in Patients with Non-Depressed Ischemic Stroke: An Open Randomized Controlled Study. Brain Impairment. 2018 May:1-7.
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BACKGROUND
Saeterdal I, Pike E, Ringerike T, Gjertsen MK. Efficacy and Safety for the Newer Antidepressants in Adults [Internet]. Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2007 Jun. Report from Norwegian Knowledge Centre for the Health Services (NOKC) No. 17-2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK464856/
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BACKGROUND
Sanchez C, Reines EH, Montgomery SA. A comparative review of escitalopram, paroxetine, and sertraline: Are they all alike? Int Clin Psychopharmacol. 2014 Jul;29(4):185-96. doi: 10.1097/YIC.0000000000000023.
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BACKGROUND
Sebastian R, Saxena S, Tsapkini K, Faria AV, Long C, Wright A, Davis C, Tippett DC, Mourdoukoutas AP, Bikson M, Celnik P, Hillis AE. Cerebellar tDCS: A Novel Approach to Augment Language Treatment Post-stroke. Front Hum Neurosci. 2017 Jan 12;10:695. doi: 10.3389/fnhum.2016.00695. eCollection 2016.
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BACKGROUND
Wang C, Zhang Y, Liu B, Long H, Yu C, Jiang T. Dosage effects of BDNF Val66Met polymorphism on cortical surface area and functional connectivity. J Neurosci. 2014 Feb 12;34(7):2645-51. doi: 10.1523/JNEUROSCI.3501-13.2014.
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BACKGROUND
Walker-Batson D, Curtis S, Natarajan R, Ford J, Dronkers N, Salmeron E, Lai J, Unwin DH. A double-blind, placebo-controlled study of the use of amphetamine in the treatment of aphasia. Stroke. 2001 Sep;32(9):2093-8. doi: 10.1161/hs0901.095720.
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BACKGROUND
Stockbridge MD, Fridriksson J, Sen S, Bonilha L, Hillis AE. Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial. PLoS One. 2021 Dec 23;16(12):e0261474. doi: 10.1371/journal.pone.0261474. eCollection 2021.
Reference Type
DERIVED
Other Identifiers
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IRB00268564
Identifier Type: -
Identifier Source: org_study_id
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