Clinical trial · Interventional
A Study Utilizing Escitalopram in Glioma Patients
A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Glioma of Brain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escitalopram Oral Capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Escitalopram
- description
- 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.
- interventionNames
- Drug: Escitalopram Oral Capsules
Primary outcomes (5)
- measure
- Change in Cognition
- timeFrame
- Baseline, 12-weeks and 17-weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available