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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06144294, who can take part
- Record updated
- 23 June 2026