|

A Study Utilizing Escitalopram in Glioma Patients

RECRUITINGPhase 2Sponsored by University of Nebraska
Actively Recruiting
PhasePhase 2
SponsorUniversity of Nebraska
Started2019-03-06
Est. completion2026-12
Eligibility
Age19 Years+
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 19 Years+Healthy volunteers accepted
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

Conditions3

CancerGliomaGlioma of Brain

Locations1 site

University of Nebraska Medical Center
Omaha, Nebraska, 68198
Michaela K Savine, RN402-836-9488misavine@unmc.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.