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Selective Serotonin Reuptake Inhibitor

Escitalopram for Brain Tumor

Phase 2
Recruiting
Led By Nicole A Shonka, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status ECOG 0-2 or equivalent
Patients must be age ≥19 years
Must not have
Already taking an anti-depressant (SSRI or NSRI)
Females of childbearing potential must have a negative urine pregnancy test at the study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 17 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of SSRIs on grade IV glioma patients. Changes in cognition and psychosocial factors will be measured from before treatment to 17 weeks after treatment.

Who is the study for?
This study is for adults over 19 with a specific brain tumor called Grade IV glioma, who are about to start or are currently receiving chemo and/or radiation. They should be able to perform daily activities (ECOG 0-2), have a life expectancy over 6 months, and not be pregnant. Those with severe kidney issues, depression or anxiety, visual field defects, or intolerance to similar medications cannot join.
What is being tested?
The trial tests Escitalopram Oral Capsules on patients with grade IV glioma over approximately 17 weeks. It aims to see how the drug affects cognition and psychosocial factors in these patients during their treatment period.
What are the potential side effects?
Escitalopram may cause side effects like nausea, sleepiness or insomnia, increased sweating, fatigue, dry mouth and sexual dysfunction. Some people might also experience emotional changes such as nervousness or mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I am 19 years old or older.
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I have been diagnosed with a Grade IV brain tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on an SSRI or SNRI antidepressant.
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I am of childbearing age and have a negative pregnancy test.
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I do not have partial vision loss.
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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~17 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 17 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterize the degree of change in cognition
Characterize the degree of change in cognition and brain function
Determine the degree of change in psychosocial functions

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EscitalopramExperimental Treatment1 Intervention
This is an open-label study. Escitalopram will be administered to all participants as 10 mg capsules to be taken by mouth daily for 90 days.

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,366 Total Patients Enrolled
Nicole ShonkaLead Sponsor
Nicole A Shonka, MDPrincipal InvestigatorUniversity of Nebraska
3 Previous Clinical Trials
46 Total Patients Enrolled
Nicole Shonka, MDPrincipal Investigator - University of Nebraska
Nebraska Health System-University Hospital
University Of Nebraska College Of Medicine (Medical School)
University Of Ne Medical Center (Residency)
5 Previous Clinical Trials
98 Total Patients Enrolled

Media Library

Escitalopram (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03728673 — Phase 2
Brain Tumor Research Study Groups: Escitalopram
Brain Tumor Clinical Trial 2023: Escitalopram Highlights & Side Effects. Trial Name: NCT03728673 — Phase 2
Escitalopram (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03728673 — Phase 2
~5 spots leftby Dec 2026
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