Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728673
Recruitment Status : Suspended (COVID-19 safety precautions)
First Posted : November 2, 2018
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Nicole Shonka, University of Nebraska

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

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.

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
Nicole Shonka
Investigators
Layout table for investigator information
Principal Investigator: Nicole Shonka, MD University of Nebraska
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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

Layout table for additional information
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:
Layout table for MeSH terms
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