Can an antidepressant also fight chemo nausea? new study tests mirtazapine in brain cancer patients

NCT ID NCT03935685

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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