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Mirtazapine for depression and CINV in glioma
NCT03935685Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Feb 2019
- Primary completion
- Dec 2030
- Countries
- 1
- Sponsor
- University of California, Irvine
- Modality
- Small Molecules
- Drugs
- mirtazapine
- Conditions
- major depressive disorder (MDD)nausea ((none))Vomiting
01
Overview
Phase 2, open-label trial of mirtazapine in major depressive disorder (MDD), nausea ((none)) and Vomiting, sponsored by University of California, Irvine. Primary endpoints: Beck Depression Inventory at 8 weeks and Body weight change at 8 weeks. Started Feb 2019; status: active, not recruiting.
02
Design
- Study design
- Non-randomizedOpen-labelSingle group
03
Who it enrols
Newly-diagnosed high-grade glioma patients starting temozolomide with clinical depression (BDI >= 21) and no prior TMZ or other chemotherapy.
04
Endpoints
Primary
Beck Depression Inventory
Body weight change
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