Whole-Body Hyperthermia for Mood and Anxiety Disorders

NCT06144294 | Not Yet Recruiting

• 1 other identifier: 23-01025619
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression; Mood Disorders; Anxiety Disorders; Postpartum Anxiety

Keywords

postpartum depression; mood disorders; anxiety disorders; postpartum anxiety; whole-body hyperthermia; antidepressant therapy; anxiolytic therapy; postpartum feasibility and acceptability; psychoneuroimmunology; Broad-band neural suppression; EEG; Likert scale; inflammatory activity; pro-inflammatory cytokines; precision functional brain maps; fMRI

Outcome Measures

Primary Outcomes (2)

• Percent change in EEG amplitude.

  Measure the extent of broad-band neural suppression in WBH.

  During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed.

• Percent change in EEG frequency.

  Measure the extent of broad-band neural suppression in WBH,

  During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed.

Secondary Outcomes (3)

• 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.

• Mean change in average 24-hour core temperature.

  Two days prior to the intervention and five days post-intervention.

• 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.

Study Arms (8)

Group 2 - Cohort 2a

EXPERIMENTAL

Healthy women or transgender men 18-50 years of age, \<6 months postpartum

Other: Whole-Body Hyperthermia

Group 2 - Cohort 2b

EXPERIMENTAL

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

Other: Whole-Body Hyperthermia

Group 2 - Cohort 2c

EXPERIMENTAL

Healthy adults of both sexes 18-50 years of age

Other: Whole-Body Hyperthermia

Group 2 - Cohort 2d

EXPERIMENTAL

Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Other: Whole-Body Hyperthermia

Group 3 - Cohort 2a

EXPERIMENTAL

Healthy women or transgender men 18-50 years of age, \<6 months postpartum

Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI

Group 3 - Cohort 2b

EXPERIMENTAL

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

Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI

Group 3 - Cohort 2c

EXPERIMENTAL

Healthy adults of both sexes 18-50 years of age

Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI

Group 3 - Cohort 2d

EXPERIMENTAL

Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI

Interventions

Whole-Body Hyperthermia OTHER

The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.

Also known as: Clearlight Portable Dome Sauna

Group 2 - Cohort 2a; Group 2 - Cohort 2b; Group 2 - Cohort 2c; Group 2 - Cohort 2d; Group 3 - Cohort 2a; Group 3 - Cohort 2b; Group 3 - Cohort 2c; Group 3 - Cohort 2d

fMRI DIAGNOSTIC_TEST

A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.

Group 3 - Cohort 2a; Group 3 - Cohort 2b; Group 3 - Cohort 2c; Group 3 - Cohort 2d

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Study Group 2
• Arm 1: Healthy women or transgender men 18-50 years of age, ≤ 6 months postpartum
• Arm 2: 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.
• Arm 3: Healthy adults of both sexes 18-50 years of age.
• Arm 4: Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the Mini International Neuropsychiatric Interview (MINI)
• Study Group 3

You may not qualify if:

• For logistics, we will exclude individuals with BMI \>30 and waist size \> 35, who may not fit comfortably in the sauna dome for all cohorts described above.
• For contraindications to hyperthermia, we will exclude from all cohorts listed above, individuals with severe cardiovascular disease, including congestive heart failure, coronary artery disease, uncontrolled hypertension, and hypotension; pregnancy; active substance use disorders; recent major injuries or surgeries (\<1 week prior); impaired sweating (those with multiple sclerosis, diabetes mellitus with neuropathy, central nervous system disease, heat insensitivity); a history or family history of malignant hyperthermia, fever or active signs of infection; taking medications that may have interactions with hyperthermia (for example, barbiturates, diuretics, and beta blockers) and the use of an antipyretic or anihistamine medication in the 12 hours prior to the WBH intervention. Individuals with above mentioned conditions will be excluded since either WBH might deteriorate their conditions or it is unknown how their condition will be affected by WBH.
• For contraindications to immune analyses, we will exclude individuals with conditions that might affect immune analyses, including individuals with known active autoimmune or endocrine disease and individuals with active infection at baseline.
• Study Group 2
• Arm 1: For psychiatric contraindications, we will exclude individuals with a history of psychiatric disorders as assessed by MINI since the cohort will consist of mentally healthy individuals as a control group.
• Arm 2: For psychiatric contraindications, we will exclude individuals with bipolar disorder or other Axis I psychiatric disorders except depressive and anxiety disorders and individuals taking antidepressants who are unwilling to hold antidepressant dose steady from recruitment through study termination. In this cohort we exclude individuals with other psychiatric disorders except depressive and anxiety disorders to rule out the effect of other psychiatric diseases on the outcome.
• Arm 3: For psychiatric contraindications, we will exclude individuals with a history of psychiatric disorders as assessed by MINI since the cohort will consist of mentally healthy individuals as a control group.
• Arm 4: For psychiatric contraindications, we will exclude individuals with bipolar disorder or other Axis I psychiatric disorders except depressive and anxiety disorders and individuals taking antidepressants who are unwilling to hold antidepressant dose steady from recruitment through study termination. In this cohort we exclude individuals with other psychiatric disorders except depressive and anxiety disorders to rule out the effect of other psychiatric diseases on the outcome.
• Study Group 2 and Study Group 3 - All participants
• For contraindications to use of the e-Celsius capsule that will be used to measure core temperature, we will exclude individuals with pacemakers or any other electric medical implant, individuals with a current intestinal disorder that could lead to obstruction of the digestive tract including gastroparesis, individuals with history of diverticula, individuals with history of past surgical procedures in the gastrointestinal tract, individuals with a swallowing disorder and individuals with Crohn's disease.
• Study Group 3 - All participants
• For contraindications to MRI, individuals with metal in the body will be excluded from participating in the MRI portion of the research since magnetic fields in MRI scanners can cause dangerous interactions in patients with metallic foreign bodies: projectile effect, twisting, burning, artifacts, and device malfunction (interference with a pacemaker).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related Publications (26)

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Related Links

• Clearlight Sauna Dome

MeSH Terms

Conditions

Depression, Postpartum; Mood Disorders; Anxiety Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lauren M Osborne, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Jonathan Power, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Specialist

CONTACT

212-746-2107; emt4004@med.cornell.edu

Research Program Manager

CONTACT

212-746-2106; als4044@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)