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Trial record 7 of 595 for:    ESCITALOPRAM

A Study Utilizing Escitalopram in Glioma Patients

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ClinicalTrials.gov Identifier: NCT03728673
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Nicole Shonka, University of Nebraska

Tracking Information
First Submitted Date  ICMJE October 19, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE March 6, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
N2pc amplitude changes relative to baseline [ Time Frame: 3 months ]
The N2pc is a neural measure of attentional control. The N2pc will be measured in response to a distracting stimulus during a visual search task. The N2pc will be measured in microvolts (uV)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03728673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Utilizing Escitalopram in Glioma Patients
Official Title  ICMJE A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
grade II and III glioma patients treated with SSRIs during a 3 month study period
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioma of Brain
  • Glioma
Intervention  ICMJE Drug: Escitalopram Oral Tablet
Active capsules will contain 10 mg escitalopram oxalate.
Other Names:
  • escitalopram 10mg
  • Lexapro
Study Arms  ICMJE Experimental: escitalopram
Intervention: Drug: Escitalopram Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Nurse Coordinator, RN 402-559-8065 sarah.kirke@unmc.edu
Contact: Peggy Project Manager, BA 402-559-4596 peggy.heires@unmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728673
Other Study ID Numbers  ICMJE 245-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicole Shonka, University of Nebraska
Study Sponsor  ICMJE Nicole Shonka
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicole Shonka, MD University of Nebraska
PRS Account University of Nebraska
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP