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Tocilizumab and Whole Body Hyperthermia in Major Depressive Disorder
NCT03787290Phase 2
Key facts
- Status
- Suspended
- Start
- Dec 2026
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Massachusetts General Hospital
- Modality
- Antibody Conjugates, Recombinant Proteins and Enzymes, Engineered Antibody Formats
- Drugs
- tocilizumab
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 2, randomised trial in major depressive disorder (MDD) comparing Tocilizumab + WBH with Placebo + WBH (2 arms). Primary endpoint: Inventory of Depressive Symptomatology Self-Report at 1 week. Planned start Dec 2026; status: suspended.
02
Design
2 arms- Study design
- Randomized
Tocilizumab + WBH
Participants receive a single subcutaneous injection of tocilizumab (162 mg) followed by whole-body hyperthermia.
Placebo + WBH
Participants receive a single subcutaneous injection of saline followed by whole-body hyperthermia.
03
Who it enrols
Adults aged 18-65 with Major Depressive Disorder (MDD) for at least 4 weeks, baseline IDS-C30 score >= 25, and CRP <= 5 mg/L. Excludes patients with significant medical conditions, high suicide risk, recent substance abuse, or those who have failed >4 adequate antidepressant trials.
04
Endpoints
Primary
Inventory of Depressive Symptomatology Self-Report
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