This pilot study will include grade IV glioma patients treated with SSRIs during approximately a 17 week study period. Changes in cognition and evaluation of psychosocial factors from baseline to after 17 weeks of treatment with SSRI study drug will be calculated.
Full Title of Study: “A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2022
As many as 85% of glioma patients experience cognitive impairment. This is not only from direct tumor involvement, but also worsens with therapy such as cranial radiation and chemotherapy, which further degrade neuronal function. Commonly, impairments in visuospatial skills and executive function are seen. There is evidence that serotonin selective reuptake inhibitors (SSRIs) such as escitalopram improve modulation and function of resting state networks, contribute to neuroplastic changes in brain regions subserving these abilities, and provide general functional support to neuronal cells. In addition to either improving cognition or preventing cognitive decline, treatment with an SSRI may also improve outcomes critical to overall survival in this vulnerable population, including functional independence, psychosocial stability, and quality of life. We hypothesize that following treatment with escitalopram patients will experience improved cognitive and mood function over time. We will also correlate changes in mood structural MRI and electrophysiological correlates of visual pathway function. The addition of escitalopram has the potential to enhance cognitive function and hence functional independence thereby improving quality of life in these patients.
- Drug: Escitalopram Oral Tablet
- Active capsules will contain 10 mg escitalopram oxalate.
Arms, Groups and Cohorts
- Experimental: escitalopram
Clinical Trial Outcome Measures
- Change in response amplitude and/or latency of evoked retino-cortical activity
- Time Frame: 17 weeks
- The dark-adapted b-wave is an electroretinographic measure of inner retinal function within the rod-driven visual pathway. The b-wave will be measured in response to a flashing light stimulus while the patient is dark-adapted after 20 minutes. The b-wave will be measured in microvolts (uV).
Participating in This Clinical Trial
- Patient with pathologically proven diagnosis of Grade IV glioma – Patients planning to receive chemotherapy and/or radiation for newly diagnosed disease – Performance status ECOG 0-2 or equivalent – Patients must be age ≥19 years – Life expectancy greater than 6 months – Written informed consent to participate in the study. Exclusion Criteria:
- Hemifield defects (as this obscures visual field necessary to participate in all tests) – Inability to undergo MRI – Severe renal impairment defined as 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 – Females of childbearing potential must have a negative urine pregnancy test at the study enrollment. – Female patients must be either postmenopausal, free from menses for ≥2 years, surgically sterilized, or willing to use two adequate barrier forms of contraception
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Nicole Shonka
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Nicole Shonka, Associate Professor of Medicine – University of Nebraska
- Overall Official(s)
- Nicole Shonka, MD, Principal Investigator, University of Nebraska
- Overall Contact(s)
- Jennifer Nurse Coordinator, RN, 402-559-8711, email@example.com
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