Whole-Body Hyperthermia for Mood and Anxiety Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Group 2

Trial design

Design model

Parallel

Treatments tested in this trial

  • Whole-Body Hyperthermia

    Other intervention

    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.

  • fMRI

    Diagnostic test

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

Treatment groups

240 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Group 2.1Experimental treatment 1 intervention
Group B: Group 2.2Experimental treatment 1 intervention
Group C: Group 2.3Experimental treatment 1 intervention
Group D: Group 2.4Experimental treatment 1 intervention
Group E: Group 2.1: Sub-studyExperimental treatment 2 interventions
Group F: Group 2.2: Sub-studyExperimental treatment 2 interventions
Group G: Group 2.3: Sub-studyExperimental treatment 2 interventions
Group H: Group 2.4: Sub-studyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percent change in EEG amplitude.

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

Time frame
During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed.
2

Percent change in EEG frequency.

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

Time frame
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

1

Mean change from baseline in inflammatory activity as measured by pro-inflammatory cytokines.

Determine whether peripheral immune activation predicts the effect of WBH on PPD or depressive and anxiety symptoms in non-postpartum adults.

Time frame
Two days prior to the intervention; immediately prior to intervention; immediately post-intervention; and at five days post-intervention.
2

Mean change in average 24-hour core temperature.

Determine the average change in core temperature across the whole-body hyperthermia intervention.

Time frame
Two days prior to the intervention and five days post-intervention.
3

Individualized precision functional brain maps.

Determine longitudinal changes in neural circuit activity produced by whole-body hyperthermia.

Time frame
Up to 3 fMRI scans in the 10 days before the intervention and up to 7 fMRI scans in the 6 weeks post-intervention.

Other outcomes

Sponsors and contacts

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