Using Escitalopram to Improve Cognition in Glioma Patients
A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients
This study is testing if the medication escitalopram can help improve thinking skills and mood in patients with grade IV glioma over 17 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT03728673 on ClinicalTrials.gov |
What this trial studies
This pilot study focuses on grade IV glioma patients who will be treated with the serotonin selective reuptake inhibitor escitalopram over a 17-week period. The study aims to assess changes in cognitive function and psychosocial factors before and after treatment. Given that a significant number of glioma patients experience cognitive impairment due to the tumor and its treatments, the study hypothesizes that escitalopram may enhance cognitive abilities and improve overall quality of life. Additionally, the study will explore correlations between mood changes and brain imaging results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with a pathologically confirmed diagnosis of grade IV glioma who are planning to undergo chemotherapy and/or radiation.
Not a fit: Patients with severe renal impairment, those currently taking antidepressants, or individuals with significant mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive function and quality of life for glioma patients.
How similar studies have performed: While the use of SSRIs in glioma patients is a novel approach, there is existing evidence suggesting SSRIs can improve cognitive function in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Omaha, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Nicole A Shonka, MD — University of Nebraska
- Study coordinator: Michaela K Savine, RN
- Email: misavine@unmc.edu
- Phone: 402-836-9488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.