Postpartum DepressionNCT06144294
Whole-Body Hyperthermia for Mood and Anxiety Disorders
A study testing Whole-Body Hyperthermia and fMRI in people with Postpartum Depression and Mood Disorders, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Mood Disorders, Anxiety Disorders
- What is being tested?
- Whole-Body Hyperthermia and fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2028to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 join
- 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.
- 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.
Show all 13Show fewer
- 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.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine
New York, New York, 10021
Emily Tutino, MPH, emt4004@med.cornell.edu
Jennifer Faiz, BS, jef4016@med.cornell.edu
About this study
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.
Read the detailed description
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.
- Being tested
- Whole-Body Hyperthermia, fMRI
- Keywords
- postpartum depression, mood disorders, anxiety disorders, postpartum anxiety, whole-body hyperthermia, antidepressant therapy, anxiolytic therapy, postpartum feasibility and acceptability, psychoneuroimmunology, Broad-band neural suppression, EEG, Likert scale, inflammatory activity, pro-inflammatory cytokines, precision functional brain maps, fMRI
- Medical subject headings
- Depression, Postpartum, Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body HyperthermiaOther
Also called Clearlight Portable Dome Sauna
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.
fMRIDiagnostic test
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.
| Study group | Role | What they receive |
|---|---|---|
| Group 2.1 | Experimental | Healthy women or transgender men 18-50 years of age, <6 months postpartum Receives: Other: Whole-Body Hyperthermia |
| Group 2.2 | Experimental | 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 Receives: Other: Whole-Body Hyperthermia |
| Group 2.3 | Experimental | Healthy adults of both sexes 18-50 years of age Receives: Other: Whole-Body Hyperthermia |
| Group 2.4 | Experimental | Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI Receives: Other: Whole-Body Hyperthermia |
| Group 2.1: Sub-study | Experimental | Healthy women or transgender men 18-50 years of age, <6 months postpartum Receives: Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI |
| Group 2.2: Sub-study | Experimental | 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 Receives: Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI |
| Group 2.3: Sub-study | Experimental | Healthy adults of both sexes 18-50 years of age Receives: Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI |
| Group 2.4: Sub-study | Experimental | Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI Receives: Other: Whole-Body Hyperthermia; Diagnostic Test: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in EEG amplitude.
Measure the extent of broad-band neural suppression in WBH.
Measured: 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,
Measured: 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 (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 3 fMRI scans in the 10 days before the intervention and up to 7 fMRI scans in the 6 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study startJun 2028 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren M Osborne, MD, Principal investigator, Weill Medical College of Cornell UniversityJonathan Power, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144294
- Sponsor's protocol ID
- 23-01025619
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabral R, Prior PF, Scott DF, Brierley JB. Reversible profound depression of cerebral electrical activity in hyperthermia. Electroencephalogr Clin Neurophysiol. 1977 May;42(5):697-701. doi: 10.1016/0013-4694(77)90286-3.
PubMed 67029de Labra C, Pardo-Vazquez JL, Cudeiro J, Rivadulla C. Hyperthermia-Induced Changes in EEG of Anesthetized Mice Subjected to Passive Heat Exposure. Front Syst Neurosci. 2021 Sep 9;15:709337. doi: 10.3389/fnsys.2021.709337. eCollection 2021.
PubMed 34566589Yamane T, Tateishi A, Cho S, Manabe S, Yamanashi M, Dezawa A, Yasukouchi H, Ishioka K. The effects of hyperthermia on the spinal cord. Spine (Phila Pa 1976). 1992 Nov;17(11):1386-91. doi: 10.1097/00007632-199211000-00020.
PubMed 1462216Haveman J, Geerdink AG, Rodermond HM. Cytokine production after whole body and localized hyperthermia. Int J Hyperthermia. 1996 Nov-Dec;12(6):791-800. doi: 10.3109/02656739609027685.
PubMed 8950159Landsberg L, Young JB, Leonard WR, Linsenmeier RA, Turek FW. Is obesity associated with lower body temperatures? Core temperature: a forgotten variable in energy balance. Metabolism. 2009 Jun;58(6):871-6. doi: 10.1016/j.metabol.2009.02.017.
PubMed 19375759Lynch CJ, Power JD, Scult MA, Dubin M, Gunning FM, Liston C. Rapid Precision Functional Mapping of Individuals Using Multi-Echo fMRI. Cell Rep. 2020 Dec 22;33(12):108540. doi: 10.1016/j.celrep.2020.108540.
PubMed 33357444Newbold DJ, Laumann TO, Hoyt CR, Hampton JM, Montez DF, Raut RV, Ortega M, Mitra A, Nielsen AN, Miller DB, Adeyemo B, Nguyen AL, Scheidter KM, Tanenbaum AB, Van AN, Marek S, Schlaggar BL, Carter AR, Greene DJ, Gordon EM, Raichle ME, Petersen SE, Snyder AZ, Dosenbach NUF. Plasticity and Spontaneous Activity Pulses in Disused Human Brain Circuits. Neuron. 2020 Aug 5;107(3):580-589.e6. doi: 10.1016/j.neuron.2020.05.007. Epub 2020 Jun 16.
PubMed 32778224Mason AE, Fisher SM, Chowdhary A, Guvva E, Veasna D, Floyd E, Fender SB, Raison C. Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Int J Hyperthermia. 2021;38(1):1529-1535. doi: 10.1080/02656736.2021.1991010.
PubMed 34674592Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.
PubMed 15883651Maternal depression and child development. Paediatr Child Health. 2004 Oct;9(8):575-598. doi: 10.1093/pch/9.8.575. No abstract available.
PubMed 19680490Feldman R, Granat A, Pariente C, Kanety H, Kuint J, Gilboa-Schechtman E. Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):919-927. doi: 10.1097/CHI.0b013e3181b21651.
PubMed 19625979Halligan SL, Murray L, Martins C, Cooper PJ. Maternal depression and psychiatric outcomes in adolescent offspring: a 13-year longitudinal study. J Affect Disord. 2007 Jan;97(1-3):145-54. doi: 10.1016/j.jad.2006.06.010. Epub 2006 Jul 24.
PubMed 16863660Lyons-Ruth K, Zoll D, Connell D, Grunebaum HU. The depressed mother and her one-year-old infant: environment, interaction, attachment, and infant development. New Dir Child Dev. 1986 Winter;(34):61-82. doi: 10.1002/cd.23219863407. No abstract available.
PubMed 3822211Murray L. The impact of postnatal depression on infant development. J Child Psychol Psychiatry. 1992 Mar;33(3):543-61. doi: 10.1111/j.1469-7610.1992.tb00890.x.
PubMed 1577898Righetti-Veltema M, Conne-Perreard E, Bousquet A, Manzano J. Postpartum depression and mother-infant relationship at 3 months old. J Affect Disord. 2002 Aug;70(3):291-306. doi: 10.1016/s0165-0327(01)00367-6.
PubMed 12128241
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body Hyperthermia for Mood and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT06144294
- Acronym / sponsor ID
- 23-01025619
- Keywords
- postpartum depression, mood disorders, anxiety disorders, postpartum anxiety, whole-body hyperthermia, antidepressant therapy, anxiolytic therapy, postpartum feasibility and acceptability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2028 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 2.1 | Experimental | Other: Whole-Body HyperthermiaHealthy women or transgender men 18-50 years of age, <6 months postpartum |
| Group 2.2 | Experimental | Other: Whole-Body HyperthermiaWomen 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 |
| Group 2.3 | Experimental | Other: Whole-Body HyperthermiaHealthy adults of both sexes 18-50 years of age |
| Group 2.4 | Experimental | Other: Whole-Body HyperthermiaAdults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI |
| Group 2.1: Sub-study | Experimental | Other: Whole-Body Hyperthermia, Diagnostic Test: fMRIHealthy women or transgender men 18-50 years of age, <6 months postpartum |
| Group 2.2: Sub-study | Experimental | Other: Whole-Body Hyperthermia, Diagnostic Test: fMRIWomen 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 |
| Group 2.3: Sub-study | Experimental | Other: Whole-Body Hyperthermia, Diagnostic Test: fMRIHealthy adults of both sexes 18-50 years of age |
| Group 2.4: Sub-study | Experimental | Other: Whole-Body Hyperthermia, Diagnostic Test: fMRIAdults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Group 2
- Group 2: Sub-study
Key exclusion criteria (13 listed)
- 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
- Group 2 and Group 2: Sub-study - All participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Body HyperthermiaAlso: Clearlight Portable Dome SaunaThe 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. | Other | Group 2.1, Group 2.1: Sub-study, Group 2.2, Group 2.2: Sub-study, Group 2.3, Group 2.3: Sub-study, Group 2.4, Group 2.4: Sub-study |
| fMRIA standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain. | Diagnostic test | Group 2.1: Sub-study, Group 2.2: Sub-study, Group 2.3: Sub-study, Group 2.4: Sub-study |
Primary outcome
Percent change in EEG amplitude.
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.
Measure the extent of broad-band neural suppression in WBH.
Percent change in EEG frequency.
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.
Measure the extent of broad-band neural suppression in WBH,
3 secondary outcomes
Mean change from baseline in inflammatory activity as measured by pro-inflammatory cytokines.
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.
Time frame: Two days prior to the intervention and five days post-intervention.
Individualized precision functional brain maps.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 67029Cabral R, Prior PF, Scott DF, Brierley JB. Reversible profound depression of cerebral electrical activity in hyperthermia. Electroencephalogr Clin Neurophysiol. 1977 May;42(5):697-701. doi: 10.1016/0013-4694(77)90286-3.
- Background: PubMed 34566589de Labra C, Pardo-Vazquez JL, Cudeiro J, Rivadulla C. Hyperthermia-Induced Changes in EEG of Anesthetized Mice Subjected to Passive Heat Exposure. Front Syst Neurosci. 2021 Sep 9;15:709337. doi: 10.3389/fnsys.2021.709337. eCollection 2021.
- Background: PubMed 1462216Yamane T, Tateishi A, Cho S, Manabe S, Yamanashi M, Dezawa A, Yasukouchi H, Ishioka K. The effects of hyperthermia on the spinal cord. Spine (Phila Pa 1976). 1992 Nov;17(11):1386-91. doi: 10.1097/00007632-199211000-00020.
- Background: PubMed 8950159Haveman J, Geerdink AG, Rodermond HM. Cytokine production after whole body and localized hyperthermia. Int J Hyperthermia. 1996 Nov-Dec;12(6):791-800. doi: 10.3109/02656739609027685.
- Background: PubMed 19375759Landsberg L, Young JB, Leonard WR, Linsenmeier RA, Turek FW. Is obesity associated with lower body temperatures? Core temperature: a forgotten variable in energy balance. Metabolism. 2009 Jun;58(6):871-6. doi: 10.1016/j.metabol.2009.02.017.
- Background: PubMed 33357444Lynch CJ, Power JD, Scult MA, Dubin M, Gunning FM, Liston C. Rapid Precision Functional Mapping of Individuals Using Multi-Echo fMRI. Cell Rep. 2020 Dec 22;33(12):108540. doi: 10.1016/j.celrep.2020.108540.
- Background: PubMed 32778224Newbold DJ, Laumann TO, Hoyt CR, Hampton JM, Montez DF, Raut RV, Ortega M, Mitra A, Nielsen AN, Miller DB, Adeyemo B, Nguyen AL, Scheidter KM, Tanenbaum AB, Van AN, Marek S, Schlaggar BL, Carter AR, Greene DJ, Gordon EM, Raichle ME, Petersen SE, Snyder AZ, Dosenbach NUF. Plasticity and Spontaneous Activity Pulses in Disused Human Brain Circuits. Neuron. 2020 Aug 5;107(3):580-589.e6. doi: 10.1016/j.neuron.2020.05.007. Epub 2020 Jun 16.
- Background: PubMed 34674592Mason AE, Fisher SM, Chowdhary A, Guvva E, Veasna D, Floyd E, Fender SB, Raison C. Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Int J Hyperthermia. 2021;38(1):1529-1535. doi: 10.1080/02656736.2021.1991010.
- Background: PubMed 15883651Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.
- Background: PubMed 19680490Maternal depression and child development. Paediatr Child Health. 2004 Oct;9(8):575-598. doi: 10.1093/pch/9.8.575. No abstract available.
- Background: PubMed 19625979Feldman R, Granat A, Pariente C, Kanety H, Kuint J, Gilboa-Schechtman E. Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):919-927. doi: 10.1097/CHI.0b013e3181b21651.
- Background: PubMed 16863660Halligan SL, Murray L, Martins C, Cooper PJ. Maternal depression and psychiatric outcomes in adolescent offspring: a 13-year longitudinal study. J Affect Disord. 2007 Jan;97(1-3):145-54. doi: 10.1016/j.jad.2006.06.010. Epub 2006 Jul 24.
- Clearlight Sauna DomeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Postpartum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren M Osborne, MD principal investigator
Weill Medical College of Cornell University
Jonathan Power, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Hyperthermia and fMRI in people with Postpartum Depression and Mood Disorders, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Specialist (212-746-2107, emt4004@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in EEG amplitude. (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144294, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.