Escitalopram + Language Therapy for Aphasia

(ELISA Trial)

Recruiting at 3 trial locations

Overseen By Argye Hillis-Trupe, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Antidepressants, MAOIs, Pimozide, others

Disqualifiers: Previous stroke, Schizophrenia, Severe depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

88 Participants Needed

Trial Summary

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as those approved for depression, monoamine oxidase inhibitors (MAOIs), pimozide, and other drugs that prolong the QT/QTc interval. If you are on any of these, you may need to stop them to participate.

What data supports the effectiveness of the drug escitalopram for treating aphasia?

While there is no direct evidence for escitalopram's effectiveness in treating aphasia, it has been shown to be effective in treating major depressive disorder and anxiety disorders, which suggests it may have potential benefits for brain function and mood. ^{1 2 3 4 5}

Is escitalopram safe for use in humans?

Escitalopram, also known as Lexapro or Cipralex, is a medication commonly used to treat depression and anxiety, and it has been studied in various clinical trials. Generally, it is considered safe for use in humans, but like all medications, it can have side effects, which may include nausea, sleep disturbances, and dizziness. It's important to discuss any concerns with a healthcare provider. ^{6 7 8 9 10}

How does the drug escitalopram combined with language therapy differ from other treatments for aphasia?

This treatment is unique because it combines escitalopram, a drug known for treating depression by increasing serotonin levels in the brain, with language therapy to potentially enhance recovery in aphasia, a condition affecting speech and language skills. While escitalopram is primarily used for depression, its use in aphasia is novel, as it may help improve cognitive function and language recovery when paired with targeted therapy. ^{1 2 3 4 11}

Research Team

Argye Hillis-Trupe, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for right-handed, English-speaking adults who've had a left hemisphere ischemic stroke within the past 5 days and have been diagnosed with aphasia. They must be able to consent or have someone to do it for them. Excluded are those with prior brain diseases, severe visual/hearing loss, depression medication use at stroke onset, pregnancy, certain heart risks or psychiatric conditions affecting language.

Inclusion Criteria

I can make my own medical decisions or have someone who can.

I am 18 years old or older.

I had a stroke less than 5 days ago.

Exclusion Criteria

Your heart's electrical activity (measured by ECG) is too slow or you have low sodium levels in your blood at the beginning of the study.

I am not taking MAOIs, pimozide, drugs that affect heart rhythm, or specific migraine medications.

You have uncorrected vision or hearing problems that you know about.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 mg escitalopram daily for three months, combined with speech and language treatment (SALT)

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

Treatment Details

Interventions

• Escitalopram

Trial Overview The study tests if Escitalopram (an SSRI) can improve the effectiveness of computer-delivered naming therapy for people with aphasia after a recent stroke. Participants will either receive Escitalopram or a placebo alongside their language therapy sessions.

Participant Groups

Group I: Naming Treatment + Escitalopram Experimental Treatment 2 Interventions

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 II: Naming Treatment + Placebo Placebo Group 2 Interventions

10 mg placebo daily for three months

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of South Carolina

Collaborator

Trials

233

Recruited

122,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Findings from Research

In a study of 691 geriatric patients, those treated with escitalopram showed better treatment persistence and were less likely to switch medications compared to those on citalopram, indicating escitalopram may be a more reliable option for older adults with major depressive disorder.

Patients on escitalopram experienced significantly fewer hospitalizations and lower total healthcare costs, primarily due to reduced hospitalization rates, suggesting that escitalopram not only helps manage depression effectively but also reduces overall healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of escitalopram versus citalopram for the treatment of major depressive disorder in a geriatric population. Wu, E., Greenberg, PE., Yang, E., et al.[2022]

In a pooled analysis of three clinical trials involving 506 severely depressed patients, escitalopram was found to be significantly more effective than citalopram, with a greater mean change in depression scores (p = 0.003).

The response rate for escitalopram was also higher at 56% compared to 41% for citalopram (p = 0.007), confirming its superior efficacy in treating severe depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of escitalopram in patients with severe depression: a pooled analysis. Llorca, PM., Azorin, JM., Despiegel, N., et al.[2013]

In a study involving 72 patients aged 65-78 with chronic brain ischemia and depression, escitalopram was effective in treating depression and reducing the risk of dementia over a 6-month treatment period.

Both low (5 mg) and higher (10 mg) doses of escitalopram were used, showing that the medication can help manage cognitive dysfunction associated with depression in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of different doses of escitalopram in the prevention of dementia in patients with depression and moderate cognitive dysfunction associated with chronic brain ischemia]. Zhitkova, JV.[2022]

Escitalopram is a highly effective and well-tolerated treatment for moderate-to-severe major depressive disorder (MDD), showing consistent superiority over citalopram based on pooled clinical trial data.

Preliminary studies indicate that escitalopram's efficacy is comparable to other SSRIs and venlafaxine, with potential cost-effectiveness benefits, making it a strong first-line treatment option for MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on escitalopram in the management of major depressive disorder. Murdoch, D., Keam, SJ.[2022]

Escitalopram, the active S-enantiomer of citalopram, significantly improves depressive symptoms in patients with major depressive disorder (MDD) compared to placebo, with effects noticeable as early as 1-2 weeks into treatment, based on several 8-week, randomized, placebo-controlled studies.

The drug has a favorable safety profile, with mild and transient side effects similar to those of placebo, making it a suitable first-line treatment for MDD and potentially beneficial for anxiety disorders as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram : a review of its use in the management of major depressive and anxiety disorders. Waugh, J., Goa, KL.[2022]

Donepezil has been shown to significantly improve various aspects of language function in patients with post-stroke aphasia, including auditory comprehension, naming, repetition, and oral expression, based on a systematic review of 15 studies involving 578 participants.

Memantine also demonstrated efficacy in enhancing naming ability, spontaneous speech, and repetition, although it did not show significant improvement in auditory comprehension, indicating that different pharmacological treatments may have varying effects on language recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Pharmacological Treatments for Post-stroke Aphasia. Zhang, X., Shu, B., Zhang, D., et al.[2019]

A study found a significant gap between the treatment dosage used in research studies for aphasia interventions and what is typically provided in outpatient clinical settings, with research showing a median of 20 hours of treatment compared to only 7.5 hours in practice.

This dosage gap may reduce the effectiveness of aphasia treatments when applied in real-world settings, suggesting a need for future research to focus on aligning clinical practices with evidence-based dosages to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Research-Practice Dosage Gap in Aphasia Rehabilitation? Cavanaugh, R., Kravetz, C., Jarold, L., et al.[2022]

This study will evaluate the effectiveness of escitalopram, a selective serotonin reuptake inhibitor, in enhancing language therapy for individuals with post-stroke aphasia, with 88 participants enrolled over four years.

The trial aims to determine if escitalopram improves language outcomes independently of its effects on depression and how factors like lesion location and genetic variations may influence treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial. Stockbridge, MD., Fridriksson, J., Sen, S., et al.[2022]

In a study involving 34 adults with chronic post-stroke aphasia, distributed therapy (6 hours per week for 8 weeks) led to significantly greater improvements in language impairment, as measured by the Boston Naming Test, compared to intensive therapy (16 hours per week for 3 weeks).

Both therapy schedules resulted in similar gains in communicative effectiveness, confidence, and quality of life, suggesting that while distributed therapy may be more effective for language impairment, both approaches positively impact overall communication outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Versus Distributed Aphasia Therapy: A Nonrandomized, Parallel-Group, Dosage-Controlled Study. Dignam, J., Copland, D., McKinnon, E., et al.[2016]

A 3-week Intensive Comprehensive Aphasia Program (ICAP) for 46 individuals with poststroke aphasia resulted in significant improvements in language abilities across all four main domains (speaking, writing, auditory comprehension, and reading), with the most notable gains in speaking.

These improvements were not only substantial but also sustained over a 12-week follow-up period, indicating that high-dose therapy can lead to meaningful long-term benefits in both language skills and functional communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of the Queen Square Intensive Comprehensive Aphasia Service for Patients With Poststroke Aphasia. Leff, AP., Nightingale, S., Gooding, B., et al.[2022]

Escitalopram is an effective treatment for major depressive disorder (MDD) with a potentially faster onset of action compared to citalopram, and it is generally well tolerated, with nausea being the most common side effect.

Pharmacoeconomic analyses indicate that escitalopram is more cost-effective than other SSRIs and the SNRI venlafaxine XR, with lower direct costs associated with its use, making it a strong candidate for first-line therapy in MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on the pharmacoeconomics of escitalopram in depression. Croom, KF., Plosker, GL.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of escitalopram versus citalopram for the treatment of major depressive disorder in a geriatric population. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Efficacy of escitalopram in patients with severe depression: a pooled analysis. [2013]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Comparison of different doses of escitalopram in the prevention of dementia in patients with depression and moderate cognitive dysfunction associated with chronic brain ischemia]. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on escitalopram in the management of major depressive disorder. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Escitalopram : a review of its use in the management of major depressive and anxiety disorders. [2022]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Pharmacological Treatments for Post-stroke Aphasia. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Is There a Research-Practice Dosage Gap in Aphasia Rehabilitation? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Protocol for Escitalopram and Language Intervention for Subacute Aphasia (ELISA): A randomized, double blind, placebo-controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Intensive Versus Distributed Aphasia Therapy: A Nonrandomized, Parallel-Group, Dosage-Controlled Study. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of the Queen Square Intensive Comprehensive Aphasia Service for Patients With Poststroke Aphasia. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on the pharmacoeconomics of escitalopram in depression. [2022]