NCT05366270

Peripheral Neuroimmune Mechanisms of Hyperthermia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a maximum of 42-day randomized controlled trial (RCT) of Whole Body Hyperthermia (WBH) vs. Sham for subjects with depressive symptoms at the Depression Clinical Research Program (DCRP) at Massachusetts General Hospital (MGH). 60 subjects with Major Depressive Disorder (MDD), males and females, between the ages of 18 and 65 years will be recruited and undergo a screening visit prior to being randomized to receive a single treatment of WBH or sham. The primary endpoint will be measurement of Interleukin-6 (IL-6) and other inflammation associated proteins (cytokines and heat shock proteins) in the plasma at one hour, 24h and one-week post WBH. A further endpoint is treatment response defined by a decrease of 50% or more in the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-CR) score at 7 days post-intervention, 2 weeks post-intervention, and 4 weeks post-intervention.

Conditions

• Hyperthermia
• Major Depressive Disorder
• Inflammation

Interventions

Type	Name	Description
DEVICE	WBH	Hyperthermia exposure using Heckel Hyperthermia Device
DEVICE	Sham	Sham (mild heating) using Heckel Hyperthermia Device

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2022-05-09
• Last updated: 2023-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study