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Trial record 3 of 21 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | Glioma | United States | Start date from 01/01/2019 to 03/31/2019

A Study Utilizing Escitalopram in Glioma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03728673
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : March 12, 2019
Information provided by (Responsible Party):
Nicole Shonka, University of Nebraska

Brief Summary:
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.

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.

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Study Type : Interventional
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

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

Primary Outcome Measures :
  1. 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)

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

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

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 identifier (NCT number): NCT03728673

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Contact: Sarah Nurse Coordinator, RN 402-559-8065
Contact: Peggy Project Manager, BA 402-559-4596

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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
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Principal Investigator: Nicole Shonka, MD University of Nebraska

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Responsible Party: Nicole Shonka, Associate Professor of Medicine, University of Nebraska 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
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
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
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents