An interventional study of Whole-Body Hyperthermia and fMRI in Postpartum Depression, Mood Disorders and Anxiety Disorders, sponsored by Weill Medical College of Cornell University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Basic science
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.
Whole-body hyperthermia has already been shown to be feasible, acceptable, and effective in major depressive disorder (MDD) populations, with an open-label study and a subsequent randomized, double-blind, sham-controlled study both demonstrating efficacy. Some evidence indicates that the antidepressant effect may be due to immune mechanisms, though it may also be mediated through direct neural effects of hyperthermia
This project aims to establish a protocol to deliver WBH therapy to patients with mood and anxiety disorders to collect information about scientific mechanisms. It also seeks to extend treatment to a specific population: a single session WBH treatment could be of tremendous interest to depressed postpartum women who wish to avoid medications and time away from their infants.
The mechanistic work will be completed with the four cohorts. By examining mechanisms in all four groups, investigators will be able to determine mechanisms unique to ill individuals as well as any mechanistic differences between MDD and PPD. In addition, the investigators aim to establish feasibility and acceptability of this protocol in postpartum women. Why? Over 80% of women deliver a child, and 15-20% of all women develop significant postpartum mental illness, usually depression and anxiety.
Participants will be divided into two groups: those undergoing a simplified protocol to test feasibility and acceptability in the postpartum (Group 1) and those undergoing a more time-intensive protocol to evaluate mechanisms (Group 2). In addition, participants in Group 2 will be eligible to enroll in a sub-study (Group 2: Sub-Study) including up to 10 fMRI session.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 240 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group 2
Group 2: Sub-study
Exclusion criteria for all:
Additional exclusion criteria by cohort or applicable study group:
Group 2
Group 2 and Group 2: Sub-study - All participants
Study Group 3 - All participants
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy women or transgender men 18-50 years of age, \<6 months postpartum
Other: Whole-Body Hyperthermia
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
Healthy adults of both sexes 18-50 years of age
Other: Whole-Body Hyperthermia
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
Healthy women or transgender men 18-50 years of age, \<6 months postpartum
Other: Whole-Body Hyperthermia · Diagnostic Test: fMRI
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
Healthy adults of both sexes 18-50 years of age
Other: Whole-Body Hyperthermia · Diagnostic Test: fMRI
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
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
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.
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.
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.
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.
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.
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.
Plan to share: No
Start is estimated for Jun 2028; primary completion for Dec 2031, 42 months later.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 42 months is above that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Weill Medical College of Cornell University →