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ACTIVE NOT RECRUITING
NCT03935685
PHASE2

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

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2019-02-26

Completion Date

2030-12-31

Last Updated

2025-09-24

Healthy Volunteers

No

Conditions

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.

Locations (1)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States