Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ (NCT03935685) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ
United States120 participantsStarted 2019-02-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depression level in glioma patients on temozolomide therapy treated with Mirtazapine
Timeframe: 8 weeks
2
Patient Weight Change
Timeframe: 8 weeks
3
Frequency and grade of nausea and vomiting in depressed glioma patients on temozolomide therapy treated with Mirtazapine