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Whole-Body Hyperthermia for Mood and Anxiety Disorders

Key facts

Who runs it
Weill Medical College of Cornell University
Where
New York, United StatesSee the site
Trial code
Status
Not yet recruiting
People taking part
240 people, planned
Starts
Jun 2028
Expected to end
Dec 2032
Type of study
Interventional, 8 groups
Treatments tested
  • Whole-Body Hyperthermia
  • fMRI
Record updated
23 June 2026

Who can take part

Age
18 years to 50 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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)
  • Group 2: Sub-study; Subjects enrolled in Group 2 are eligible for an optional additional sub-study (Group 2: Sub-study); inclusion criteria are the same as for Group 2

Who cannot take part

  • 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; Additional exclusion criteria by cohort or applicable study group:
  • 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
  • Group 2 and Group 2: Sub-study - 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
  • 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
  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 50 years old?

Where in United States

  • Weill Cornell MedicineNew York, United StatesContact: Emily Tutino, MPHNot yet recruiting

About the trial

What the trial wants to find out

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.

The 8 groups in the trial

  • Group 2.1Treatment being tested

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

    Treatment: Whole-Body Hyperthermia

  • Group 2.2Treatment being tested

    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

    Treatment: Whole-Body Hyperthermia

  • Group 2.3Treatment being tested

    Healthy adults of both sexes 18-50 years of age

    Treatment: Whole-Body Hyperthermia

  • Group 2.4Treatment being tested

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

    Treatment: Whole-Body Hyperthermia

  • Group 2.1: Sub-studyTreatment being tested

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

    Treatment: Whole-Body Hyperthermia and fMRI

  • Group 2.2: Sub-studyTreatment being tested

    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

    Treatment: Whole-Body Hyperthermia and fMRI

  • Group 2.3: Sub-studyTreatment being tested

    Healthy adults of both sexes 18-50 years of age

    Treatment: Whole-Body Hyperthermia and fMRI

  • Group 2.4: Sub-studyTreatment being tested

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

    Treatment: Whole-Body Hyperthermia and fMRI

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT06144294, who can take part
Record updated
23 June 2026