A Study Utilizing Escitalopram in Glioma Patients

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03728673
• Other study ID #: 0245-18-FB
• Status: Recruiting
• Phase: Phase 2
• Start date: March 6, 2019
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: University of Nebraska
• Contact: Michaela K Savine, RN
• Phone: 402-836-9488
• Email: misavine[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma of Brain

Intervention

Drug:
• Escitalopram Oral Capsules
Active capsules will contain 10 mg escitalopram oxalate.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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