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Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ

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ClinicalTrials.gov Identifier: NCT03935685
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Daniela A. Bota, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE February 26, 2019
Estimated Primary Completion Date August 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Depression level in glioma patients on temozolomide therapy treated with Mirtazapine [ Time Frame: 8 weeks ]
    The assessment is conducted using the Beck Depression Inventory. The scoring scale ranges from 1 to 63. Participants with a baseline depression score of 21 or more will be classified as depressed and will be issued a prescription for mirtazapine. Total depression score between baseline and eight weeks will be compared for each patient. Distributional properties of the data will be assessed using appropriate statistical method to examine whether there is statistically significant improvement or not.
  • Patient Weight Change [ Time Frame: 8 weeks ]
    To estimate the ability of mirtazapine to maintain weight in depressed glioma patients undergoing Temozolomide (TMZ) therapy. Weight change for each patient between baseline and 8 week will be calculated and analyzed using applicable statistical method.
  • Frequency and grade of nausea and vomiting in depressed glioma patients on temozolomide therapy treated with Mirtazapine [ Time Frame: 8 weeks ]
    To assess the patient's level of nausea and vomiting on a nausea/vomiting scale of 1 to 7. Lower value indicates less nausea and vomiting; while higher value indicates more nausea and vomiting. Data will be assessed using appropriate statistical method to examine whether there is statistically significant improvement or not.
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 8 weeks ]
    To monitor the adverse event of Mirtazapine over the course of the study. AEs will be graded according to CTCAE V5.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Percentage of adherence to mirtazapine regimen [ Time Frame: 8 weeks ]
    The percentage will be calculated based on patient's pill diary entries. Higher percentage indicates patient is more compliant.
  • Frequency of dose modifications of mirtazapine [ Time Frame: 8 weeks ]
    The dose of mirtazapine can be adjusted based on patients' conditions and adverse event reports per protocol. This is defined as the number of times that the mirtazapine dose has to be modified for each patient.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ
Official Title  ICMJE Pilot Study of Mirtazapine for the Dual Treatment of Depression and Temozolomide-Induced Nausea and Vomiting (CINV) in Newly-Diagnosed High-Grade Glioma Patients on Temozolomide Therapy
Brief Summary The purpose of the study is to estimate the ability of mirtazapine to reduce depression, nausea, and vomiting, and maintain weight in depressed glioma patients undergoing Temozolomide (TMZ) therapy. Of equal importance, the investigators will monitor the tolerability of Mirtazapine in these patients over the course of the study.
Detailed Description

Research Hypothesis: For glioma patients undergoing TMZ chemotherapy, Mirtazapine will address TMZ-associated nausea and vomiting (CINV) and weight loss in addition to depression. Mirtazapine acts as an antagonist at the 5-HT3 receptor, which may explain its anti-emetic properties. Mirtazapine is also an appetite stimulant, which may help curb the weight loss associated with TMZ chemotherapy.

Specific aim 1: To administer the Beck Depression Inventory to approximately 100 patients meeting the inclusion/exclusion criteria in order to identify at least 36 with clinical depression (defined as total score >= 21).

Specific aim 2: To put at least 36 clinically depressed patients identified in aim one on mirtazapine for eight weeks.

Specific aim 3: To administer the Beck Depression Inventory to patients from aim two at four weeks and at eight weeks of treatment with mirtazapine.

Specific aim 4: To document weight and frequencies of nausea, vomiting, and insomnia among participants over the course of the study.

Specific aim 5: To document adverse events experienced by participants over the course of the study and determine, to the extent possible, if mirtazapine is the cause.

The investigators will:

  1. Assess changes in the distribution of depression scores as measured by the Beck Depression Inventory (a self-administered instrument extensively used and validated in glioma studies) from baseline to after eight weeks of treatment with mirtazapine.
  2. Assess changes in nausea, vomiting, Sleeping and body weight between baseline and the eight-week follow-up visit,
  3. Document the trajectory of changes in depression, nausea, vomiting, and weight over the three study time points (baseline, four-week, and eight-week visit).
  4. Lastly, collect information on the tolerability of mirtazapine in our patient population.

Main Research Hypothesis: The investigators hypothesize that the mirtazapine regimen will improve depression scores at eight-weeks, compared to baseline scores. Further, the investigators hypothesize that the mirtazapine regimen will limit the reduction of weight and the incidence of nausea/vomiting and insomnia at eight weeks compared to baseline.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioma of Brain
Intervention  ICMJE Drug: Mirtazapine (Remeron)
Eligible patients should start Mirtazapine 15mg and stay there unless not tolerated, If there is no improvement in nausea dose can be increased to 30 mg and respectively 45 mg, 4 days apart. If excessive sleep, dose can be doubled. Patients should not take tryptophan while they are part of the study.
Study Arms  ICMJE Experimental: mirtazapine in glioma patients treated with Temozolomide
Using the well-known Beck Depression Inventory, we will assess the changes in depression scores from baseline to after four and eight weeks of treatment with mirtazapine. We will also assess the change in nausea, vomiting, and weight at the same time points, and collect information on tolerability of mirtazapine throughout the course of the study.
Intervention: Drug: Mirtazapine (Remeron)
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: April 30, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 9, 2020
Estimated Primary Completion Date August 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Understand and voluntarily sign and date an informed consent document prior to any study related assessments/procedures are conducted.
  • Histologically confirmed diagnosis of glioma
  • No prior treatment with temozolomide TMZ
  • Patient will receive temozolomide TMZ therapy as part of their standard treatment.
  • Males and Females ≥18 years of age at the time of signing the informed consent document. Able to understand consent forms and study materials in English
  • Willing to use approved methods of contraception for duration of study
  • Karnofsy Performance Score (KPS) of at least 60
  • Patients should have stopped any anti-depressant medications by standard of care at least a month before enrolling in the trial
  • Willing and able to adhere to the study visit schedule and other protocol requirements.
  • Adequate hematological, renal, and hepatic function (assessment performed within 14 days prior to starting treatment):

    • Absolute neutrophil count ≥ 1.5 X 109 /L
    • Platelets ≥ 100 X 109 /L
    • Serum creatinine, Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal
    • AST, ALT, Alk Phos ≤ 2.5 times upper limit of laboratory normal

Exclusion Criteria:

  • Prior treatment with other chemotherapy drugs for glioma
  • Known hypersensitivity to Mirtazapine and 5-HT3 receptor antagonists
  • Life expectancy of less than three months
  • Pregnancy or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: UC Irvine Health Chao Family Comprehensive Cancer Center 1-877-UC-STUDY UCstudy@uci.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935685
Other Study ID Numbers  ICMJE UCI 18-83
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 Daniela A. Bota, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniela Bota, MD PHD University of California, Irvine
PRS Account University of California, Irvine
Verification Date April 2019

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