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Behavioural Intervention

Whole-Body Hyperthermia for Postpartum Depression

N/A

Waitlist Available

Led By Jonathan Power, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study Group 2: 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

Study Group 2: 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)

Must not have

For contraindications to hyperthermia, individuals with severe cardiovascular disease, pregnancy, active substance use disorders, recent major injuries or surgeries (<1 week prior), impaired sweating, a history or family history of malignant hyperthermia, fever or active signs of infection, taking medications that may have interactions with hyperthermia, and the use of an antipyretic medication in the 12 hours prior to the WBH intervention will be excluded from all cohorts

Study Group 2 and Study Group 3 - All participants: Individuals with pacemakers or any other electric medical implant, individuals with a current intestinal disorder that could lead to obstruction of the digestive tract, 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 will be excluded from using the e-Celsius capsule

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 fmri scans in the 10 days before the intervention and up to 7 fmri scans in the 6 weeks post-intervention.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not explicitly listed here, potential risks may include discomfort due to heat exposure during WBH treatment such as sweating, dehydration, or heat-related stress on the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman or transgender man, aged 18-50, within 6 months postpartum, and have been diagnosed with postpartum depression.

Select...

I am between 18-50 years old and have been diagnosed with major depression or generalized anxiety.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe heart issues, am not pregnant, do not use substances, have not had recent major surgery, can sweat normally, have no family history of malignant hyperthermia, am not feverish or infected, am not on conflicting medications, and haven't taken fever reducers recently.

Select...

I do not have a pacemaker, intestinal blockages, past GI surgeries, swallowing disorders, or Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the course of the intervention: when participant core temperature reaches 38.5 c for two consecutive minutes or after 140 minutes have passed.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the course of the intervention: when participant core temperature reaches 38.5 c for two consecutive minutes or after 140 minutes have passed.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the course of the intervention: when participant core temperature reaches 38.5 c for two consecutive minutes or after 140 minutes have passed. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change in EEG amplitude.

Percent change in EEG frequency.

Secondary study objectives

Individualized precision functional brain maps.

Mean change from baseline in inflammatory activity as measured by pro-inflammatory cytokines.

Mean change in average 24-hour core temperature.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Group 3 - Cohort 2dExperimental Treatment2 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 2cExperimental Treatment2 Interventions

Healthy adults of both sexes 18-50 years of age

Group III: Group 3 - Cohort 2bExperimental Treatment2 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 2aExperimental Treatment2 Interventions

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

Group V: Group 2 - Cohort 2dExperimental Treatment1 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 2cExperimental Treatment1 Intervention

Healthy adults of both sexes 18-50 years of age

Group VII: Group 2 - Cohort 2bExperimental Treatment1 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 2aExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fMRI

2019

Completed Phase 3

~1730

0 / 4Eligibility criteria met