A Study Utilizing Escitalopram in Glioma Patients
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ClinicalTrials.gov Identifier: NCT03728673 |
Recruitment Status :
Suspended
(COVID-19 safety precautions)
First Posted : November 2, 2018
Last Update Posted : June 26, 2020
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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.
We hypothesize that following treatment with escitalopram patients will experience improved cognitive and mood function over time. We will also correlate changes in mood with EEG and structural 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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | grade IV glioma patients treated with SSRIs during a 17 week study period |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: escitalopram |
Drug: Escitalopram Oral Tablet
Active capsules will contain 10 mg escitalopram oxalate.
Other Names:
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- N2pc amplitude changes relative to baseline [ Time Frame: 17 weeks ]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)

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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

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
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | Nicole Shonka, MD | University of Nebraska |
Responsible Party: | Nicole Shonka, Associate Professor of Medicine, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT03728673 |
Other Study ID Numbers: |
245-18 |
First Posted: | November 2, 2018 Key Record Dates |
Last Update Posted: | June 26, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
serotonin selective reuptake inhibitor cognition escitalopram |
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Dexetimide Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |