Whole-Body Hyperthermia for Mood and Anxiety Disorders

Not Applicable

Not yet recruiting

• Conditions: Postpartum Anxiety; Postpartum Depression; Anxiety Disorders; Mood Disorders
• Interventions: Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI

• Registration Number: NCT06144294
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Study Start: 2025-06
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3 - Cohort 2b	Whole-Body Hyperthermia	Women and transgender men 18-50 years of age, \<6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI
Group 3 - Cohort 2b	fMRI	Women and transgender men 18-50 years of age, \<6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI
Group 3 - Cohort 2d	Whole-Body Hyperthermia	Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI
Group 2 - Cohort 2b	Whole-Body Hyperthermia	Women and transgender men 18-50 years of age, \<6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI
Group 3 - Cohort 2a	Whole-Body Hyperthermia	Healthy women or transgender men 18-50 years of age, \<6 months postpartum
Group 3 - Cohort 2a	fMRI	Healthy women or transgender men 18-50 years of age, \<6 months postpartum
Group 2 - Cohort 2a	Whole-Body Hyperthermia	Healthy women or transgender men 18-50 years of age, \<6 months postpartum
Group 2 - Cohort 2d	Whole-Body Hyperthermia	Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI
Group 2 - Cohort 2c	Whole-Body Hyperthermia	Healthy adults of both sexes 18-50 years of age
Group 3 - Cohort 2c	Whole-Body Hyperthermia	Healthy adults of both sexes 18-50 years of age
Group 3 - Cohort 2c	fMRI	Healthy adults of both sexes 18-50 years of age
Group 3 - Cohort 2d	fMRI	Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Primary Outcome Measures

Name	Time	Method
Percent change in EEG frequency.	During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed.	Measure the extent of broad-band neural suppression in WBH,
Percent change in EEG amplitude.	During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed.	Measure the extent of broad-band neural suppression in WBH.

Secondary Outcome Measures

Name	Time	Method
Mean change in average 24-hour core temperature.	Two days prior to the intervention and five days post-intervention.	Determine the average change in core temperature across the whole-body hyperthermia intervention.
Mean change from baseline in inflammatory activity as measured by pro-inflammatory cytokines.	Two days prior to the intervention; immediately prior to intervention; immediately post-intervention; and at five days post-intervention.	Determine whether peripheral immune activation predicts the effect of WBH on PPD or depressive and anxiety symptoms in non-postpartum adults.
Individualized precision functional brain maps.	Up to 3 fMRI scans in the 10 days before the intervention and up to 7 fMRI scans in the 6 weeks post-intervention.	Determine longitudinal changes in neural circuit activity produced by whole-body hyperthermia.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States