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

NCT03935685 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Daniela Bota, MD PHD · University of California, Irvine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935685 on ClinicalTrials.gov