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

NCT03935685 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20194907UCI 18-83
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma of Brain

Outcome Measures

Primary Outcomes (4)

• Depression level in glioma patients on temozolomide therapy treated with Mirtazapine

  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.

  8 weeks

• Patient Weight Change

  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.

  8 weeks

• Frequency and grade of nausea and vomiting in depressed glioma patients on temozolomide therapy treated with Mirtazapine

  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.

  8 weeks

• Incidence of Treatment-Emergent Adverse Events

  To monitor the adverse event of Mirtazapine over the course of the study. AEs will be graded according to CTCAE V5.

  8 weeks

Secondary Outcomes (2)

• Percentage of adherence to mirtazapine regimen

  8 weeks

• Frequency of dose modifications of mirtazapine

  8 weeks

Study Arms (1)

mirtazapine in glioma patients treated with Temozolomide

EXPERIMENTAL

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.

Drug: Mirtazapine (Remeron)

Interventions

Mirtazapine (Remeron) DRUG

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.

mirtazapine in glioma patients treated with Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Interventions

Mirtazapine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Daniela Bota, MD PHD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean, Clinical Research

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: May 2, 2019
• Study Start: February 26, 2019
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)