Can an antidepressant also fight chemo nausea? new study tests mirtazapine in brain cancer patients
NCT ID NCT03935685
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 pilot study is testing whether mirtazapine, an antidepressant, can help with depression, nausea, vomiting, and weight loss in people with high-grade glioma who are starting temozolomide chemotherapy. The study enrolled 120 adults with newly diagnosed glioma. Researchers will track changes in depression scores, nausea/vomiting levels, weight, and side effects over eight weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mirtazapine (Remeron)
- What this could lead to
- If it works, this could point toward a way to manage both depression and nausea in brain cancer patients, improving their quality of life during chemotherapy.
- What could go wrong
- This is a small, early-phase pilot study with no placebo group, so results may not be definitive. Mirtazapine can cause drowsiness and other side effects, and it may not help everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2019
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
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