Not Yet RecruitingNot Applicable

Whole-Body Hyperthermia for Mood and Anxiety Disorders

United States240 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * 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 * Subjects enrolled in Study Group 2 are eligible for an optional additional sub-study (Study Group 3); inclusion criteria are the same as for Study Group 2. Exclusion criteria for all: * 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…

What they're measuring

Percent change in EEG amplitude.

Timeframe: 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.

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

Trial details

NCT IDNCT06144294

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Research Specialist

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

View on ClinicalTrials.gov More Postpartum Depression trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent change in EEG amplitude.

Timeframe: 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.

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