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NCT03935685 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ
A Phase 2 study of Glioma of Brain, sponsored by University of California, Irvine.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT03935685: Active Phase 2 study of Glioma of Brain, sponsored by University of California, Irvine.
NCT03935685 is a Phase 2 study of Glioma of Brain that is active but no longer recruiting, run by University of California, Irvine. The registered enrollment target is 120 participants, above the 44-participant average among 3 other Glioma of Brain trials with a reported enrollment target (173% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03935685, a Phase 2 study of Glioma of Brain, is active but no longer recruiting, sponsored by University of California, Irvine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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. Of equal importance, the investigators will monitor the tolerability of Mirtazapine in these patients over the course of the study.
Primary Outcome
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 n
Conditions Studied
Interventions
- DRUG Mirtazapine (Remeron)
Study Locations (1)
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-02-26 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03935685 still lists
NCT03935685 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 44-participant average among 3 other Glioma of Brain trials with a reported enrollment target (173% higher).
The record links to 1 condition, with Glioma of Brain appearing as the primary indexed condition, and to 1 intervention - of which Mirtazapine (Remeron) is the first listed.
NCT03935685 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03935685 about?
NCT03935685 is a clinical study titled "Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ". 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...
What is the current status of trial NCT03935685?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2019-02-26. Estimated completion is 2030-12-31.
What conditions does trial NCT03935685 study?
This clinical trial studies the following conditions: Glioma of Brain.
What interventions are being tested in trial NCT03935685?
The interventions under investigation include: Mirtazapine (Remeron) (DRUG).
Who is sponsoring clinical trial NCT03935685?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03935685 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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