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A Study Utilizing Escitalopram in Glioma Patients

RecruitingPhase 2Ages 19 Years - anyAllUniversity of Nebraska
NCT03728673 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Glioma is a cancer of glial cells, a class of tissue supporting neuronal function in the brain. As many as 85% of glioma patients experience cognitive impairment. This is not only from direct tumor involvement, but also from therapy such as cranial radiation and chemotherapy, which degrades neuronal function. There is evidence that serotonin selective reuptake inhibitors (SSRIs), such as escitalopram, improve cognition or prevent cognitive decline and may also improve outcomes critical to overall survival including functional independence, psychosocial stability, and quality of life. This pilot study will evaluate the effectiveness of the selective serotonin reuptake inhibitor (SSRI) escitalopram for treating cognitive impairment in newly diagnosed grade IV glioma over a 17 week treatment period.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pathologically proven diagnosis of Grade IV glioma * Newly diagnosed disease to receive chemotherapy and/or radiation * Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 or equivalent * 19 years of age or older * Life expectancy greater than 6 months * Able to provide written informed consent for study participation * Negative urine pregnancy test at enrollment for females of childbearing potential * Female participants must be either post-menopausal (free from menses for 2 or more years), surgically sterilized, or willing to use two adequate barrier forms of contraception Exclusion Criteria: * Hemifield defects (obscures visual field necessary to participate in all tests) * Inability to undergo MRI * Severe renal impairment defined as Glomerular Filtration Rate (GFR) \<30 mL/minute * Screen positive for depression or anxiety * Already taking an anti-depressant (SSRI or NSRI) * Have problems tolerating past treatment with SSRI or NSRIs
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What it tests

  • Escitalopram Oral Capsules
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Where

1 site
University of Nebraska Medical Center
Omaha, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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