A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients

Who is this study for? Patients with glioma
What treatments are being studied? Escitalopram
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
United States
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Contact Information
Primary
Michaela K Savine, RN
misavine@unmc.edu
402-836-9488
Time Frame
Start Date: 2019-03-06
Estimated Completion Date: 2027-08
Participants
Target number of participants: 20
Treatments
Experimental: Escitalopram
In this open-label study, Escitalopram will be administered to all participants as 10 mg capsules to be taken by mouth daily for 90 days.
Related Therapeutic Areas
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov