Whole Body Hyperthermia (WBH) for Hyperthermia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hyperthermia+6 More
WBH - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.

Eligible Conditions
  • Hyperthermia
  • Major Depressive Disorder (MDD)
  • Inflammation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

Hour 24
Changes in mood, as measured by the Positive and Negative Affect Schedule (PANAS)
Decreases in depressive severity, as measured by the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-CR)
Decreases in depressive severity, as measured by the Symptoms of Depression Questionnaire (SDQ)
Hour 24
Changes in serum levels of Interleukin-6 from baseline to post-treatment
baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention
Changes in mental and physical functioning, as measured by the Patient Rated Outcome Measure Information System, 29-Item (PROMIS-29)
Changes to quality of life, as measured by the Quality of Life, Enjoyment, and Satisfaction Questionnaire
Changes to quality of life, as measured by the World Health Organization Wellbeing Index (WHO-5)
Reduction in perceived stress, as measured by the Perceived Stress Scale (PSS)
Reductions in ruminative thinking, as measured by the Ruminative Responses Scale (RRS)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Whole Body Hyperthermia (WBH)
1 of 2
Sham
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Whole Body Hyperthermia (WBH) · Has Placebo Group · N/A

Whole Body Hyperthermia (WBH)
Device
Experimental Group · 1 Intervention: WBH · Intervention Types: Device
Sham
Device
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,673 Previous Clinical Trials
30,828,596 Total Patients Enrolled
1 Trials studying Hyperthermia
35 Patients Enrolled for Hyperthermia
National Institute of General Medical Sciences (NIGMS)NIH
217 Previous Clinical Trials
90,823 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to provide informed consent.
You have a current primary psychiatric diagnosis of major depressive disorder (MDD) of at least 4 weeks duration, as defined by Diagnostic & Statistical Manual, 5th Edition (DSM-5) criteria using the MINI.
You have a score of 24 or higher on the Inventory of Depressive Symptomatology - Clinician Rating.
You are of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.