NCT03728673

A Study Utilizing Escitalopram in Glioma Patients

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Escitalopram Oral Capsules	Active capsules will contain 10 mg escitalopram oxalate.

Timeline

• Start date: 2019-03-06
• Primary completion: 2027-06-01
• Completion: 2029-06-01
• First posted: 2018-11-02
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study