Glioma of BrainPhase 2NCT03935685
Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ
A Phase 2 study testing Mirtazapine (Remeron) in people with Glioma of Brain, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma of Brain
- What is being tested?
- Mirtazapine (Remeron)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this 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
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.
Read the 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:
- 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.
- Assess changes in nausea, vomiting, Sleeping and body weight between baseline and the eight-week follow-up visit,
- Document the trajectory of changes in depression, nausea, vomiting, and weight over the three study time points (baseline, four-week, and eight-week visit).
- 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
- Being tested
- Mirtazapine (Remeron)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine (Remeron)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| mirtazapine in glioma patients treated with Temozolomide | Experimental | Using the well-known Beck Depression Inventory, we will assess the changes in depression scores from baseline to after four and eight weeks of treatment with mirtazapine. We will also assess the change in nausea, vomiting, and weight at the same time points, and collect information on tolerability of mirtazapine throughout the course of the study. Receives: Drug: Mirtazapine (Remeron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression level in glioma patients on temozolomide therapy treated with Mirtazapine
The assessment is conducted using the Beck Depression Inventory. The scoring scale ranges from 1 to 63. Participants with a baseline depression score of 21 or more will be classified as depressed and will be issued a prescription for mirtazapine. Total depression score between baseline and eight weeks will be compared for each patient. Distributional properties of the data will be assessed using appropriate statistical method to examine whether there is statistically significant improvement or not.
Measured: 8 weeks
Patient Weight Change
To estimate the ability of mirtazapine to maintain weight in depressed glioma patients undergoing Temozolomide (TMZ) therapy. Weight change for each patient between baseline and 8 week will be calculated and analyzed using applicable statistical method.
Measured: 8 weeks
Frequency and grade of nausea and vomiting in depressed glioma patients on temozolomide therapy treated with Mirtazapine
To assess the patient's level of nausea and vomiting on a nausea/vomiting scale of 1 to 7. Lower value indicates less nausea and vomiting; while higher value indicates more nausea and vomiting. Data will be assessed using appropriate statistical method to examine whether there is statistically significant improvement or not.
Measured: 8 weeks
Incidence of Treatment-Emergent Adverse Events
To monitor the adverse event of Mirtazapine over the course of the study. AEs will be graded according to CTCAE V5.
Measured: 8 weeks
Secondary outcomes (2)
Percentage of adherence to mirtazapine regimen
The percentage will be calculated based on patient's pill diary entries. Higher percentage indicates patient is more compliant.
Measured: 8 weeks
Frequency of dose modifications of mirtazapine
The dose of mirtazapine can be adjusted based on patients' conditions and adverse event reports per protocol. This is defined as the number of times that the mirtazapine dose has to be modified for each patient.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start26 Feb 2019
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma of BrainStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela A. Bota, University of California, Irvine
- Investigators
- Daniela Bota, MD PHD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935685
- Sponsor's protocol ID
- 20194907
- Other IDs
- UCI 18-83
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2019
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03935685
- Acronym / sponsor ID
- 20194907
- Conditions
- Glioma of Brain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Assess changes in nausea, vomiting, Sleeping and body weight between baseline and the eight-week follow-up visit,
- Document the trajectory of changes in depression, nausea, vomiting, and weight over the three study time points (baseline, four-week, and eight-week visit).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mirtazapine in glioma patients treated with Temozolomide | Experimental | Drug: Mirtazapine (Remeron)Using the well-known Beck Depression Inventory, we will assess the changes in depression scores from baseline to after four and eight weeks of treatment with mirtazapine. We will also assess the change in nausea, vomiting, and weight at the same time points, and collect information on tolerability of mirtazapine throughout the course of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | mirtazapine in glioma patients treated with Temozolomide |
Primary outcome
Depression level in glioma patients on temozolomide therapy treated with Mirtazapine
Time frame: 8 weeks
The assessment is conducted using the Beck Depression Inventory. The scoring scale ranges from 1 to 63. Participants with a baseline depression score of 21 or more will be classified as depressed and will be issued a prescription for mirtazapine. Total depression score between baseline and eight weeks will be compared for each patient. Distributional properties of the data will be assessed using appropriate statistical method to examine whether there is statistically significant improvement or not.
Patient Weight Change
Time frame: 8 weeks
To estimate the ability of mirtazapine to maintain weight in depressed glioma patients undergoing Temozolomide (TMZ) therapy. Weight change for each patient between baseline and 8 week will be calculated and analyzed using applicable statistical method.
Frequency and grade of nausea and vomiting in depressed glioma patients on temozolomide therapy treated with Mirtazapine
Time frame: 8 weeks
To assess the patient's level of nausea and vomiting on a nausea/vomiting scale of 1 to 7. Lower value indicates less nausea and vomiting; while higher value indicates more nausea and vomiting. Data will be assessed using appropriate statistical method to examine whether there is statistically significant improvement or not.
Incidence of Treatment-Emergent Adverse Events
Time frame: 8 weeks
To monitor the adverse event of Mirtazapine over the course of the study. AEs will be graded according to CTCAE V5.
2 secondary outcomes
Percentage of adherence to mirtazapine regimen
Time frame: 8 weeks
Frequency of dose modifications of mirtazapine
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Bota, MD PHD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirtazapine (Remeron) in people with Glioma of Brain, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression level in glioma patients on temozolomide therapy treated with Mirtazapine (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.