A Study Utilizing Escitalopram in Glioma Patients

A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Glioma of Brain
• Intervention / Treatment: Drug: Escitalopram Oral Capsules

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 structural MRI and electrophysiological correlates of visual pathway function. 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
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Erin E Rogers, BS; Phone Number: 402-559-0963; Email: errogers@unmc.edu
• Study Contact Backup: Name: Michaela K Savine, RN; Phone Number: 402-836-9488; Email: misavine@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Michaela K Savine, RN; Phone Number: 402-836-9488; Email: misavine@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Escitalopram; This is an open-label study. Escitalopram will be administered to all participants as 10 mg capsules to be taken by mouth daily for 90 days.	Drug: Escitalopram Oral Capsules; Active capsules will contain 10 mg escitalopram oxalate.; Other Names: Lexapro; escitalopram 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the degree of change in cognition	Changes in cognition will be measured using the NIH Toolbox neurocognitive assessments. The NIH Toolbox has excellent test / re-test reliability across composite domain scores r = .86 - .9263. It has also shown strong convergent (r = .78 - .9) and discriminant (r = .19 - .39) validities. It has been validated on groups of patients with Spinal Cord Injuries, Traumatic Brain Injury and Stroke. More recently a small group of patients diagnosed with diffuse glioma completed the NIH Toolkit Cognitive and Emotional batteries pre- and post-surgery. Results suggested good tolerance on the part of the patients and benefits of having a standardized battery that can be employed across sites. Paired t-test will be used to determine if the changes from baseline to the 17 week visit are significant. If assumptions for the paired t-test are not met, the non-parametric Wilcoxon sign rank test will be used instead.	17 weeks
Characterize the degree of change in cognition and brain function	Changes in cognition and brain function will be measured via Patient-Reported Outcome Measurement Information System (PROMIS) Neuro-QoL Item Bank v2.0 - Cognitive Function assessment completed at baseline, 12 weeks, and 17 weeks. A higher score on this measure indicate higher cognitive function. The change from baseline will be compared with the Wilcoxon sign rank test.	17 weeks
Determine the degree of change in psychosocial functions	The degree of change in psychosocial functions will be assessed via patient-reported ratings in mood and quality of life. The following assessments will be completed: PROMIS Neuro-QoL Item Bank v1.0 - Depression; PROMIS Neuro-QoL Item Bank v1.0 - Anxiety; PROMIS Neuro-QoL Item Bank v1.0 - Fatigue. Higher scores on these assessments indicate higher levels of the concept being assessed. The changes from baseline will be compared with the Wilcoxon sign rank test.	17 weeks

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Nicole A Shonka, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cognition; escitalopram; serotonin selective reuptake inhibitor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Selective Serotonin Reuptake Inhibitors; Citalopram; Dexetimide; Escitalopram
• Other Study ID Numbers: 0245-18-FB

Drug and device information, study documents

• 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