Whole-Body Hyperthermia for Postpartum Depression

Overseen By Lauren M Osborne, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must not be taking: Barbiturates, Diuretics, Beta blockers

Disqualifiers: Severe cardiovascular disease, Pregnancy, Active substance use, Recent major injuries, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies whole-body hyperthermia (WBH), a treatment using controlled heat exposure, to help improve mood and reduce anxiety. It focuses on women with postpartum depression (PPD) who prefer non-medication treatments. WBH works by affecting the immune system and brain function.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but it does mention that participants taking antidepressants must keep their dose steady throughout the study. Additionally, if you are taking medications like barbiturates, diuretics, or beta blockers, you may be excluded due to potential interactions with the treatment.

Is whole-body hyperthermia safe for humans?

Whole-body hyperthermia has been used in cancer treatment and can cause side effects like fatigue, nausea, diarrhea, and changes in heart and liver function. While it can be safe under careful monitoring, it has potential risks, including serious toxicity and, in rare cases, fatalities. ^{1 2 3 4 5}

How does whole-body hyperthermia treatment differ from other treatments for postpartum depression?

Whole-body hyperthermia (WBH) is a unique treatment for postpartum depression as it involves raising the body's core temperature using infrared heating, unlike standard treatments like psychotherapy and antidepressant medications. This non-drug approach is promising for depression with low risk of side effects, but it still requires more evidence for widespread clinical use. ^{6 7 8 9 10}

Who Is on the Research Team?

Lauren M Osborne, PhD

Principal Investigator

Weill Medical College of Cornell University

Jonathan Power, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for healthy postpartum women or transgender men, and adults with major depression or anxiety disorders. Participants must be aged 18-50, and for postpartum individuals, within 6 months after giving birth. The study excludes anyone outside this age range or not meeting the specific mental health criteria.

Inclusion Criteria

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 logistics, individuals with BMI >30 and waist size > 35 will be excluded from all cohorts

Study Group 3 - All participants: Individuals with metal in the body will be excluded from participating in the MRI portion of the research

Study Group 2: Arm 3 - Individuals with a history of psychiatric disorders as assessed by MINI will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a single session of whole-body hyperthermia (WBH) therapy to examine scientific mechanisms and assess feasibility and acceptability

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in core temperature, inflammatory activity, and neural circuit activity post-intervention

6 weeks

Up to 7 fMRI scans and multiple assessments

What Are the Treatments Tested in This Trial?

Interventions

• Whole-Body Hyperthermia

Trial Overview The trial is testing whole-body hyperthermia (WBH) as a treatment for mood and anxiety disorders including postpartum depression. It involves one session of WBH therapy and tracks changes using fMRI scans in various participant groups over time to assess effectiveness.

How Is the Trial Designed?

Group I: Group 3 - Cohort 2d Experimental Treatment 2 Interventions

Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Group II: Group 3 - Cohort 2c Experimental Treatment 2 Interventions

Healthy adults of both sexes 18-50 years of age

Group III: Group 3 - Cohort 2b Experimental Treatment 2 Interventions

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

Group IV: Group 3 - Cohort 2a Experimental Treatment 2 Interventions

Healthy women or transgender men 18-50 years of age, \<6 months postpartum

Group V: Group 2 - Cohort 2d Experimental Treatment 1 Intervention

Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Group VI: Group 2 - Cohort 2c Experimental Treatment 1 Intervention

Healthy adults of both sexes 18-50 years of age

Group VII: Group 2 - Cohort 2b Experimental Treatment 1 Intervention

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

Group VIII: Group 2 - Cohort 2a Experimental Treatment 1 Intervention

Healthy women or transgender men 18-50 years of age, \<6 months postpartum

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

A single session of whole-body hyperthermia (WBH) using a commercially available infrared sauna successfully raised participants' core body temperature to 101.3°F, which is associated with reduced depressive symptoms in previous studies.

Participants reported significant reductions in self-reported negative affect and depression symptoms from one week before to one week after the WBH session, suggesting that this non-pharmacologic treatment may be effective for major depressive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Mason, AE., Fisher, SM., Chowdhary, A., et al.[2022]

Whole-body hyperthermia (WBH) has shown promising effects on mood and depression symptoms, with 19 out of 21 study endpoints demonstrating significant effect sizes (Cohen's d of 0.8 or greater) across 7 studies involving 148 participants.

WBH interventions, which included hot baths and infrared heating, were generally safe with low risk of adverse reactions, but the evidence is still insufficient for broad clinical recommendations, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application? Hanusch, KU., Janssen, CW.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Aspects of thermoregulatory physiology pertinent to hyperthermic treatment of cancer. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Physiologic response and toxicity in patients undergoing whole-body hyperthermia for the treatment of cancer. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Whole-body hyperthermia in cancer therapy: a report of a phase I-II study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Whole body hyperthermia: a phase-I trial of a potential adjuvant to chemotherapy. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Systemic thermotherapy (whole body hyperthermia). [2016]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application? [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Management of postpartum depression. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Postpartum depression screening scale: Spanish version. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging Studies of Postpartum Depression: An Overview. [2022]