Clinical trial NCT03728673: A Study Utilizing Escitalopram in Glioma Patients
Official title: A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioma of Brain
Glioma
Keywords: serotonin selective reuptake inhibitor
cognition
escitalopram
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: grade IV glioma patients treated with SSRIs during a 17 week study period
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterize the degree of change in cognition
timeFrame: 17 weeks
measure: Characterize the degree of change in cognition and brain function
timeFrame: 17 weeks
measure: Determine the degree of change in psychosocial functions
timeFrame: 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Nicole A Shonka, MD
role: PRINCIPAL_INVESTIGATOR
References: