A Study Utilizing Escitalopram in Glioma Patients
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|ClinicalTrials.gov Identifier: NCT03728673|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioma of Brain Glioma||Drug: Escitalopram Oral Tablet||Phase 2|
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.
This pilot study will include grade II and III glioma patients treated with SSRIs during a 3 month study period. Changes in cognition and evaluation of psychosocial factors from baseline to after three months of treatment with SSRI study drug will be calculated. The investigators hypothesize that neural measures of cognition following treatment with escitalopram will experience improved cognitive and mood measures over time. The investigators will also correlate changes in mood with EEG and resting state functional (rsf)MRI. The addition of escitalopram has the potential to enhance cognitive function and hence functional independence thereby improving quality of life in these patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||grade II and III glioma patients treated with SSRIs during a 3 month study period|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients|
|Actual Study Start Date :||March 6, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||July 2021|
Drug: Escitalopram Oral Tablet
Active capsules will contain 10 mg escitalopram oxalate.
- N2pc amplitude changes relative to baseline [ Time Frame: 3 months ]The N2pc is a neural measure of attentional control. The N2pc will be measured in response to a distracting stimulus during a visual search task. The N2pc will be measured in microvolts (uV)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728673
|Contact: Sarah Nurse Coordinator, RNfirstname.lastname@example.org|
|Contact: Peggy Project Manager, BAemail@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Sarah nurse coordinator 402-559-8065|
|Principal Investigator:||Nicole Shonka, MD||University of Nebraska|