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Tocilizumab in treatment-refractory major depressive disorder
NCT02660528Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 2016
- Primary completion
- Jun 2020
- Countries
- 1
- Sponsor
- Brigham and Women's Hospital
- Modality
- Antibody Conjugates, Recombinant Proteins and Enzymes, Engineered Antibody Formats
- Drugs
- tocilizumab
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 2, open-label, single-arm trial of tocilizumab in major depressive disorder (MDD), sponsored by Brigham and Women's Hospital. Primary endpoint: Absolute Change on Hamilton Depression Rating Scale at 8 weeks. Started Apr 2016; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Tocilizumab
Tocilizumab 162 mg sc q2weeks x 4 doses
03
Who it enrols
Patients with treatment-refractory major depressive disorder (HDRS > 20) on antidepressant therapy for at least 8 weeks.
04
Endpoints
Primary
Absolute Change on Hamilton Depression Rating Scale
Secondary
Proportion of Subjects Achieving Remission
Proportion of Subjects Achieving Response
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