NCT03935685

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma of Brain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-26
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2019-05-02
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study