Clinical trial · Interventional
Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma of Brain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mirtazapine (Remeron) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mirtazapine in glioma patients treated with Temozolomide
- description
- 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.
- interventionNames
- Drug: Mirtazapine (Remeron)
Primary outcomes (4)
- measure
- Depression level in glioma patients on temozolomide therapy treated with Mirtazapine
- timeFrame
- 8 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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