A Study Utilizing Escitalopram in Glioma Patients

NCT03728673 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 0245-18-FB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Glioma is a cancer of glial cells, a class of tissue supporting neuronal function in the brain. As many as 85% of glioma patients experience cognitive impairment. This is not only from direct tumor involvement, but also from therapy such as cranial radiation and chemotherapy, which degrades neuronal function. There is evidence that serotonin selective reuptake inhibitors (SSRIs), such as escitalopram, improve cognition or prevent cognitive decline and may also improve outcomes critical to overall survival including functional independence, psychosocial stability, and quality of life. This pilot study will evaluate the effectiveness of the selective serotonin reuptake inhibitor (SSRI) escitalopram for treating cognitive impairment in newly diagnosed grade IV glioma over a 17 week treatment period.

Conditions

Glioma of Brain; Glioma

Keywords

serotonin selective reuptake inhibitor; cognition; escitalopram

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline, 12-weeks and 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.

  Baseline, 12-weeks and 17-weeks

• Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Depression

  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.

  Baseline, 12-weeks and 17-weeks

• Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Anxiety

  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.

  Baseline, 12-weeks and 17-weeks

• Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Fatigue

  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.

  Baseline, 12-weeks and 17-weeks

Study Arms (1)

Escitalopram

EXPERIMENTAL

In this 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

Interventions

Escitalopram Oral Capsules DRUG

Active capsules will contain 10 mg escitalopram oxalate.

Also known as: escitalopram 10mg, Lexapro

Escitalopram

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven diagnosis of Grade IV glioma
• Newly diagnosed disease to receive chemotherapy and/or radiation
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 or equivalent
• years of age or older
• Life expectancy greater than 6 months
• Able to provide written informed consent for study participation
• Negative urine pregnancy test at enrollment for females of childbearing potential
• Female participants must be either post-menopausal (free from menses for 2 or more years), surgically sterilized, or willing to use two adequate barrier forms of contraception

You may not qualify if:

• Hemifield defects (obscures visual field necessary to participate in all tests)
• Inability to undergo MRI
• Severe renal impairment defined as Glomerular Filtration Rate (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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nicole A Shonka, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaela K Savine, RN

CONTACT

402-836-9488; misavine@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Grade IV glioma or grade III astrocytoma participants will be treated with the selective serotonin reuptake inhibitor (SSRI) Escitalopram during a 17 week study period.

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: November 2, 2018
• Study Start: March 6, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)