A Study Utilizing Escitalopram in Glioma Patients
Status: | Recruiting |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 3/14/2019 |
Start Date: | March 6, 2019 |
End Date: | July 2021 |
Contact: | Sarah Nurse Coordinator, RN |
Email: | sarah.kirke@unmc.edu |
Phone: | 402-559-8065 |
A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients
This pilot study will include grade II and III glioma patients treated with SSRIs during a 3
month study period. Changes in cognition and evaluation of psychosocial factors from baseline
to after three months of treatment with SSRI study drug will be calculated.
month study period. Changes in cognition and evaluation of psychosocial factors from baseline
to after three months of treatment with SSRI study drug will be calculated.
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.
This pilot study will include grade II and III glioma patients treated with SSRIs during a 3
month study period. Changes in cognition and evaluation of psychosocial factors from baseline
to after three months of treatment with SSRI study drug will be calculated. The investigators
hypothesize that neural measures of cognition following treatment with escitalopram will
experience improved cognitive and mood measures over time. The investigators will also
correlate changes in mood with EEG and resting state functional (rsf)MRI. The addition of
escitalopram has the potential to enhance cognitive function and hence functional
independence thereby improving quality of life in these patients.
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.
This pilot study will include grade II and III glioma patients treated with SSRIs during a 3
month study period. Changes in cognition and evaluation of psychosocial factors from baseline
to after three months of treatment with SSRI study drug will be calculated. The investigators
hypothesize that neural measures of cognition following treatment with escitalopram will
experience improved cognitive and mood measures over time. The investigators will also
correlate changes in mood with EEG and resting state functional (rsf)MRI. The addition of
escitalopram has the potential to enhance cognitive function and hence functional
independence thereby improving quality of life in these patients.
Inclusion Criteria:
- Patient with pathologically proven diagnosis of Glioma Grade II or III glioma
- Patients scheduled to receive - or has completed - chemotherapy and/or radiation
- Performance status ECOG 0-2 or equivalent
- Patients who have previously taken SSRI or NSRIs in the past for less than 6 months,
at some point in their lives and more than 5 years prior to enrollment would be
eligible.
- Complaints of cognitive impairment of any kind by the patient during clinical visits
- 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
- Score of 26 or higher on Montreal Cognitive Assessment (MoCA) assessment
- Already taking an anti-depressant (SSRI or NSRI) or taken an SSRI or NSRI for greater
than 6 months, at some point in their life or within the last 5 years, would not be
eligible.
- Have problems tolerating past treatment with SSRI or NSRIs
- Females of childbearing potential must not be pregnant 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
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