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Antidepressant

Mirtazapine for Brain Tumor

Phase 2
Recruiting
Led By Daniela Bota, MD PHD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient will receive temozolomide TMZ therapy as part of their standard treatment.
Patients should have stopped any anti-depressant medications by standard of care at least a month before enrolling in the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will study whether mirtazapine can help reduce depression, nausea, vomiting, and weight loss in people with glioma who are undergoing temozolomide therapy.

Who is the study for?
This trial is for adults over 18 with high-grade glioma who are about to start Temozolomide therapy and have not used it before. They must be able to perform daily activities at a moderate level (KPS of at least 60), understand English, sign consent forms, agree to use contraception, and have stopped antidepressants for a month.Check my eligibility
What is being tested?
The study tests if Mirtazapine can help reduce depression, nausea, vomiting, and maintain weight in patients with brain tumors undergoing Temozolomide chemotherapy. It also checks how well patients tolerate the drug during treatment.See study design
What are the potential side effects?
Possible side effects of Mirtazapine may include drowsiness, increased appetite leading to weight gain, dry mouth, constipation or diarrhea. Each patient's experience with side effects might vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be treated with temozolomide as part of my cancer care.
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I stopped taking antidepressants at least a month ago.
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I have never been treated with temozolomide.
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My diagnosis is glioma, confirmed through tissue examination.
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I need some help with daily activities but can care for most of my personal needs.
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I am 18 or older and understand English well enough to comprehend consent forms and study materials.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression level in glioma patients on temozolomide therapy treated with Mirtazapine
Frequency and grade of nausea and vomiting in depressed glioma patients on temozolomide therapy treated with Mirtazapine
Incidence of Treatment-Emergent Adverse Events
+1 more
Secondary outcome measures
Frequency of dose modifications of mirtazapine
Percentage of adherence to mirtazapine regimen

Trial Design

1Treatment groups
Experimental Treatment
Group I: mirtazapine in glioma patients treated with TemozolomideExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,881 Total Patients Enrolled
Daniela Bota, MD PHDPrincipal InvestigatorUniversity of California, Irvine

Media Library

Mirtazapine (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT03935685 — Phase 2
Brain Tumor Research Study Groups: mirtazapine in glioma patients treated with Temozolomide
Brain Tumor Clinical Trial 2023: Mirtazapine Highlights & Side Effects. Trial Name: NCT03935685 — Phase 2
Mirtazapine (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03935685 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on other case studies that have used Mirtazapine (Remeron)?

"Mirtazapine, or Remeron, is being trialed in 225 different clinical studies. 27 of those trials have progressed to Phase 3 testing. Most of the tests are taking place in Seoul and Songpa, South Korea; though, there are 4,849 total locations running trials for this medication."

Answered by AI

Are there any well-documented dangers to taking Mirtazapine (Remeron)?

"While there is some data supporting Mirtazapine's safety, it did not receive a score of 3 because there is no efficacy data."

Answered by AI

does this research project investigating a new treatment have precedent?

"First studied in 2002, Mirtazapine (Remeron) completed its first clinical trial with 60 participants. The drug sponsor was Schering-Plough. After the success of the initial study, Mirtazapine (Remeron) received Phase 2 approval and is now being trialed in 225 separate cases across 950 cities and 37 countries."

Answered by AI

What is the most popular application of Mirtazapine (Remeron)?

"Mirtazapine (Remeron) is typically used to plan for end-of-life care. However, it can also be prescribed to treat refractory neuroblastoma, panic attacks, and major depressive disorder."

Answered by AI

How many test subjects are there in this experiment?

"That is correct, the website clinicaltrials.gov has information stating that this trial is looking for volunteers right now. The listing says that the trial was first posted on February 26th, 2019 and updated April 15th, 2021. They are hoping to find 120 patients willing to participate at 1 location."

Answered by AI

Are we still looking for participants in this clinical trial?

"The clinical trial detailed on clinicaltrials.gov is currently recruiting patients. This research was originally made public on February 26th, 2019 with the most recent update taking place on April 15th, 2021."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ
Daniela A. Bota 2019. "Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03935685.
~14 spots leftby Dec 2024
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