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A Study Utilizing Escitalopram in Glioma Patients

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Dec 2026 to Jun 2027 Completion date: Aug 2027 to Jun 2029v15 Show 1 more changeShow less
    • Completion date: Aug 2027 to Jun 2029
  2. Notable Primary endpoints: 3 to 5 Eligibility criteria revised · Study description expanded, about 21 wordsv14 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study description expanded, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Primary completion date: Dec 2024 to Dec 2026 Completion date: Aug 2025 to Aug 2027v13 Show 1 more changeShow less
    • Completion date: Aug 2025 to Aug 2027
  4. Minor Re-verified, no change to tracked fieldsv12
  5. Minor Primary completion date: Jul 2024 to Dec 2024 Completion date: Dec 2024 to Aug 2025v11 Show 1 more changeShow less
    • Completion date: Dec 2024 to Aug 2025
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Site contact updatedv10
  2. Notable Lead sponsor: Nicole Shonka to University of Nebraska Primary completion date: Jul 2023 to Jul 2024 · Primary endpoints: 1 to 3 · Completion date: Dec 2023 to Dec 2024 · 1 morev9 Show 4 more changesShow less
    • Primary completion date: Jul 2023 to Jul 2024
    • Primary endpoints: 1 to 3
    • Completion date: Dec 2023 to Dec 2024
    • Interventions: Escitalopram Oral Tablet (Drug) to Escitalopram Oral Capsules (Drug)

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Site contact updatedv8
  4. Minor 2 versions Re-verified since May 12, 2023, no change to tracked fieldsv6-v7
  5. Notable Primary completion date: Jul 2022 to Jul 2023 Completion date: Dec 2022 to Dec 2023v5 Show 1 more changeShow less
    • Completion date: Dec 2022 to Dec 2023
  6. Notable Trial status: Suspended to Recruiting Primary completion date: Dec 2020 to Jul 2022 · Primary endpoint revised · Completion date: Jul 2021 to Dec 2022 · 2 morev4 Show 5 more changesShow less
    • Primary completion date: Dec 2020 to Jul 2022
    • Primary endpoint revised
    • Completion date: Jul 2021 to Dec 2022
    • Site details revised
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  7. Stopped Trial status: Recruiting to Suspended Sponsor's reason: COVID-19 safety precautions Eligibility criteria shortened, about 85 words · Study description shortened, about 50 words · Site details revisedv3 Show 3 more changesShow less
    • Eligibility criteria shortened, about 85 words
    • Study description shortened, about 50 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  8. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 2018 to Mar 6, 2019v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2018 to Mar 6, 2019
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT03728673
Lead Sponsor University of Nebraska
Conditions Glioma of Brain, Glioma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov