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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study Utilizing Escitalopram in Glioma Patients

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

A Study Utilizing Escitalopram in Glioma Patients (NCT03728673) is a Phase 2 interventional studying Glioma of Brain and Glioma, sponsored by University of Nebraska. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Glioma of Brain and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - expected to live at least 6 months - Able to provide written willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Escitalopram Oral Capsules

Active capsules will contain 10 mg escitalopram oxalate.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Nebraska Medical Center
Omaha, Nebraska, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03728673), the sponsor (University of Nebraska), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03728673 clinical trial studying?

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 pilo… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03728673?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03728673?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03728673. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03728673. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.