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

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Nicole Shonka, University of Nebraska

Study Description

Brief Summary:

Condition or disease	Intervention/treatment	Phase
Glioma of Brain Glioma	Drug: Escitalopram Oral Tablet	Phase 2

Detailed Description:

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 Design

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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)
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

Resource links provided by the National Library of Medicine

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

Genetic and Rare Diseases Information Center resources: Glioma Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: escitalopram	Drug: Escitalopram Oral Tablet Active capsules will contain 10 mg escitalopram oxalate. Other Names: escitalopram 10mg Lexapro

Outcome Measures

Primary Outcome Measures :

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)

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

Inclusion Criteria:

Patient with pathologically proven diagnosis of Glioma Grade II or III glioma
Patients scheduled to receive - or has completed - chemotherapy and/or radiation
Performance status ECOG 0-2 or equivalent
Patients who have previously taken SSRI or NSRIs in the past for less than 6 months, at some point in their lives and more than 5 years prior to enrollment would be eligible.
Complaints of cognitive impairment of any kind by the patient during clinical visits
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
Score of 26 or higher on Montreal Cognitive Assessment (MoCA) assessment
Already taking an anti-depressant (SSRI or NSRI) or taken an SSRI or NSRI for greater than 6 months, at some point in their life or within the last 5 years, would not be eligible.
Have problems tolerating past treatment with SSRI or NSRIs
Females of childbearing potential must not be pregnant 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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts

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Contact: Sarah Nurse Coordinator, RN	402-559-8065	sarah.kirke@unmc.edu
Contact: Peggy Project Manager, BA	402-559-4596	peggy.heires@unmc.edu

Locations

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United States, Nebraska
University of Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68198
Contact: Sarah nurse coordinator 402-559-8065

Sponsors and Collaborators

Nicole Shonka

Investigators

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Principal Investigator:	Nicole Shonka, MD	University of Nebraska

More Information

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Responsible Party:	Nicole Shonka, Associate Professor of Medicine, University of Nebraska
ClinicalTrials.gov Identifier:	NCT03728673 History of Changes
Other Study ID Numbers:	245-18
First Posted:	November 2, 2018 Key Record Dates
Last Update Posted:	March 12, 2019
Last Verified:	March 2019

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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

Keywords provided by Nicole Shonka, University of Nebraska:


serotonin selective reuptake inhibitor cognition escitalopram

Additional relevant MeSH terms:

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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

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