A Study Utilizing Escitalopram in Glioma Patients

• ClinicalTrials.gov Identifier: NCT03728673
• Recruitment Status: Recruiting
• First Posted: November 2, 2018
• Last Update Posted: March 12, 2019
• Sponsor: Nicole Shonka
• Information provided by (Responsible Party): Nicole Shonka, University of Nebraska

Tracking Information

• First Submitted Date: October 19, 2018
• First Posted Date: November 2, 2018
• Last Update Posted Date: March 12, 2019
• Actual Study Start Date: March 6, 2019
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2018)

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)

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03728673 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Utilizing Escitalopram in Glioma Patients
• Official Title: A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients
• 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.

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 Type: Interventional
• Study Phase: Phase 2

Study Design

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

Condition

• Glioma of Brain
• Glioma

Intervention

Drug: Escitalopram Oral Tablet

Active capsules will contain 10 mg escitalopram oxalate.

Other Names:

• escitalopram 10mg
• Lexapro

Study Arms

Experimental: escitalopram

Intervention: Drug: Escitalopram Oral Tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 30, 2018): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2021
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sarah Nurse Coordinator, RN; 402-559-8065; sarah.kirke@unmc.edu

Contact: Peggy Project Manager, BA; 402-559-4596; peggy.heires@unmc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03728673
• Other Study ID Numbers: 245-18
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Responsible Party: Nicole Shonka, University of Nebraska
• Study Sponsor: Nicole Shonka
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nicole Shonka, MD; University of Nebraska

• PRS Account: University of Nebraska
• Verification Date: March 2019