A Study Utilizing Escitalopram in Glioma Patients

NCT ID: NCT03728673

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2027-08-31

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.

Detailed Description

As many as 85% of patients with glioma, a cancer of glial cells, 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. 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 study will characterize the degree of change in cognition/brain function in participants with grade IV glioma planning to undergo concurrent chemoradiation therapy followed by temozolomide and 17 weeks of treatment with an SSRI, escitalopram, and determine the degree of change in psychosocial function as assessed via ratings in mood and quality of life. The study hypothesis is that following treatment with escitalopram participants will experience improved cognitive and mood function over time.

Conditions

Glioma of Brain; Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escitalopram

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.

Group Type: EXPERIMENTAL

Escitalopram Oral Capsules

Intervention Type: DRUG

Active capsules will contain 10 mg escitalopram oxalate.

Interventions

Escitalopram Oral Capsules

Active capsules will contain 10 mg escitalopram oxalate.

Intervention Type: DRUG

Other Intervention Names

escitalopram 10mg; Lexapro

Eligibility Criteria

Inclusion Criteria

• 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
• 19 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole A Shonka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michaela K Savine, RN

Role: CONTACT

misavine@unmc.edu

402-836-9488

Facility Contacts

Michaela K Savine, RN

Role: primary

misavine@unmc.edu

402-836-9488

Other Identifiers

0245-18-FB

Identifier Type: -

Identifier Source: org_study_id