NOT_YET_RECRUITING
Whole-Body Hyperthermia for Mood and Anxiety Disorders
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.
Conditions:
🦠 Postpartum Depression 🦠 Mood Disorders 🦠 Anxiety Disorders 🦠 Postpartum Anxiety
🗓️ Study Start (Actual) December 2024
🗓️ Primary Completion (Estimated) December 2028
✅ Study Completion (Estimated) December 2029
👥 Enrollment (Estimated) 240
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

  • Inclusion Criteria
  • * Study 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)
  • * Study Group 3
  • * Subjects enrolled in Study Group 2 are eligible for an optional additional sub-study (Study Group 3); inclusion criteria are the same as for Study Group 2.
  • Exclusion criteria for all:
  • * 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 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:
  • * Study 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.
  • * Study Group 2 and Study Group 3 - 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).
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 November 2023
  • First Submitted that Met QC Criteria 16 November 2023
  • First Posted 22 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 May 2024
  • Last Update Posted 24 May 2024
  • Last Verified May 2024