Recruiting
Phase 2

Escitalopram

Sponsor:

University of Nebraska

Code:

NCT03728673

Conditions

Glioma of Brain

Glioma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Escitalopram Oral Capsules

Study Details

Brief 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.

Conditions

Glioma of Brain

Glioma

Study ID

NCT03728673

Start date

Mar 6, 2019

Status verified date

Apr, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Escitalopram

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.

Interventions

Escitalopram Oral Capsules

Active capsules will contain 10 mg escitalopram oxalate.

Primary outcome measure

  • Change in Cognition [ Time Frame: Baseline, 12-weeks and 17-weeks ]
  • Characterize the degree of change in cognition and brain function [ Time Frame: Baseline, 12-weeks and 17-weeks ]
  • Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Depression [ Time Frame: Baseline, 12-weeks and 17-weeks ]
  • Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Anxiety [ Time Frame: Baseline, 12-weeks and 17-weeks ]
  • Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Fatigue [ Time Frame: Baseline, 12-weeks and 17-weeks ]

Central Contacts and Locations

Central contacts

Michaela K Savine, RN

402-836-9488misavine@unmc.edu

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Michaela K Savine, RN

402-836-9488misavine@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • serotonin selective reuptake inhibitor
  • cognition
  • escitalopram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-04-17.