Whole-Body Hyperthermia for Mood and Anxiety Disorders

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06144294
Status
Not Yet Recruiting

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Conditions

  • Anxiety Disorders
  • Mood Disorders
  • Postpartum Anxiety
  • Postpartum Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Whole-Body Hyperthermia — OTHER
    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.
  • fMRI — DIAGNOSTIC_TEST
    A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jul 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 2 - Cohort 2a
    Healthy women or transgender men 18-50 years of age, \<6 months postpartum
  • Experimental: Group 2 - Cohort 2b
    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
  • Experimental: Group 2 - Cohort 2c
    Healthy adults of both sexes 18-50 years of age
  • Experimental: Group 2 - Cohort 2d
    Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI
  • Experimental: Group 3 - Cohort 2a
    Healthy women or transgender men 18-50 years of age, \<6 months postpartum
  • Experimental: Group 3 - Cohort 2b
    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
  • Experimental: Group 3 - Cohort 2c
    Healthy adults of both sexes 18-50 years of age
  • Experimental: Group 3 - Cohort 2d
    Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10021
Emily Tutino, BA
[email protected]
Alexa Stufano, MPH
[email protected]
Lauren M Osborne, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Weill Cornell Medicine· New York, NY

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