MedTrace Logo

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

NCT03787290 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-11-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tocilizumab

participants will receive a single subcutaneous injection of tocilizumab (162 mg)

DRUG

Placebo

participants will receive a single subcutaneous injection of saline

DEVICE

Whole-Body Hyperthermia

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

Sponsors & Collaborators

  • heckel medizintechnik GmbH

    collaborator UNKNOWN

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2028-12-01
Completion
2029-03-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03787290 on ClinicalTrials.gov