Whole-Body Hyperthermia for Mood and Anxiety Disorders

Anxiety Disorders Clinical Trial

Official title: Whole-Body Hyperthermia for Mood and Anxiety Disorders

Status Not yet recruiting

Clinical Trial Summary

This study aims to examine the scientific mechanisms of whole-body hyperthermia (WBH), a novel, rapidly acting, single session antidepressant and anxiolytic therapy. It also aims to determine its feasibility and acceptability in women with postpartum depression (PPD). The study will enroll four cohorts of participants: healthy postpartum controls; postpartum women with PPD; healthy adult controls; and adults with major depressive disorder or anxiety disorders in a longitudinal protocol.

Clinical Trial Description

Whole-body hyperthermia has already been shown to be feasible, acceptable, and effective in major depressive disorder (MDD) populations, with an open-label study and a subsequent randomized, double-blind, sham-controlled study both demonstrating efficacy. Some evidence indicates that the antidepressant effect may be due to immune mechanisms, though it may also be mediated through direct neural effects of hyperthermia

This project aims to establish a protocol to deliver WBH therapy to patients with mood and anxiety disorders to collect information about scientific mechanisms. It also seeks to extend treatment to a specific population: a single session WBH treatment could be of tremendous interest to depressed postpartum women who wish to avoid medications and time away from their infants.

The mechanistic work will be completed with the four cohorts. By examining mechanisms in all four groups, investigators will be able to determine mechanisms unique to ill individuals as well as any mechanistic differences between MDD and PPD. In addition, the investigators aim to establish feasibility and acceptability of this protocol in postpartum women. Why? Over 80% of women deliver a child, and 15-20% of all women develop significant postpartum mental illness, usually depression and anxiety.

Participants will be divided into two groups: those undergoing a simplified protocol to test feasibility and acceptability in the postpartum (Study Group 1) and those undergoing a more time-intensive protocol to evaluate mechanisms (Study Group 2). In addition, participants in Study Group 2 will be eligible to enroll in a sub-study (Study Group 3) including up to 10 fMRI session. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Postpartum
• Fever
• Hyperthermia
• Mood Disorders
• Postpartum Anxiety
• Postpartum Depression

• NCT number: NCT06144294
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Contact: Research Specialist
• Phone: 212-746-2107
• Email: emt4004@med.cornell.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Completion date: December 2029