Mild-Intensity Whole Body Hyperthermia (WBH) for Major Depressive Disorder

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03787290
Phase
PHASE2
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    participants will receive a single subcutaneous injection of tocilizumab (162 mg)
  • Placebo — DRUG
    participants will receive a single subcutaneous injection of saline
  • Whole-Body Hyperthermia — DEVICE
    subjects' core temperature will be increased to 38.5 degrees Celsius (typically 60-120 minutes) then they will begin a 60-minute cool-down phase

Study Details

Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.

Key Dates

Start date
Dec 1, 2026
Status verified
Nov 2025
Primary completion
Dec 1, 2028
Completion
Mar 1, 2029

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Participants will receive tocilizumab followed by whole-body hyperthermia
  • Active Comparator: Placebo
    Participants will receive a placebo followed by whole-body hyperthermia

Primary Outcome Measure

Inventory of Depressive Symptomatology Self-Report (IDS-SR) [ Time Frame: Week 0 (Visit 2) to Week 1 (visit 3) [approximately 7 days] ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02139-

Find similar trials in Boston, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Massachusetts General Hospital· Boston, MA

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