Peripheral Neuroimmune Mechanisms of Hyperthermia

NCT ID: NCT05366270

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-06-30

Brief Summary

The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.

Detailed Description

The study is a maximum of 42-day randomized controlled trial (RCT) of Whole Body Hyperthermia (WBH) vs. Sham for subjects with depressive symptoms at the Depression Clinical Research Program (DCRP) at Massachusetts General Hospital (MGH). 60 subjects with Major Depressive Disorder (MDD), males and females, between the ages of 18 and 65 years will be recruited and undergo a screening visit prior to being randomized to receive a single treatment of WBH or sham. The primary endpoint will be measurement of Interleukin-6 (IL-6) and other inflammation associated proteins (cytokines and heat shock proteins) in the plasma at one hour, 24h and one-week post WBH. A further endpoint is treatment response defined by a decrease of 50% or more in the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-CR) score at 7 days post-intervention, 2 weeks post-intervention, and 4 weeks post-intervention.

Conditions

Hyperthermia; Major Depressive Disorder; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Whole Body Hyperthermia (WBH)

A single treatment of Whole Body Hyperthermia will be administered using the Heckel Hyperthermia device. During this procedure, participants' core body temperature will be elevated to 38.5 degrees Celsius.

Group Type: EXPERIMENTAL

WBH

Intervention Type: DEVICE

Hyperthermia exposure using Heckel Hyperthermia Device

Sham

Under the sham condition, participants will enter the Heckel Hyperthermia device as in the active treatment condition, but will not receive the whole body hyperthermia treatment, and will instead only receive mild heating.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Sham (mild heating) using Heckel Hyperthermia Device

Interventions

WBH

Hyperthermia exposure using Heckel Hyperthermia Device

Intervention Type: DEVICE

Sham

Sham (mild heating) using Heckel Hyperthermia Device

Intervention Type: DEVICE

Other Intervention Names

Whole Body Hyperthermia

Eligibility Criteria

Inclusion Criteria

1. Females and Males ages 18-65

2. English language proficiency

3. Ability to provide informed consent

4. Have a current primary psychiatric diagnosis of major depressive disorder (MDD) of at least 4 weeks duration, as defined by Diagnostic & Statistical Manual, 5th Edition (DSM-5) criteria using the MINI.

5. Score of ≥ 24 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)

6. Individuals of childbearing potential must use an acceptable form of birth control.

Exclusion Criteria

1. Pregnancy or planned pregnancy during study

2. Current breastfeeding

3. History of psychiatric hospitalization within the past year

4. Active suicidal intent ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)

5. History of bipolar disorder, psychotic disorders, eating disorders, and/or substance abuse or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI)

6. Meeting DSM-5 criteria at screening for current obsessive compulsive disorder

7. A ≥25% drop in IDS-CR score from screen (V1) to baseline (V1b)

8. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the investigator)

9. Serious unstable medical condition including cardiovascular, neurological, neoplastic, autoimmune, infectious or endocrine.

10. Morbid obesity (BMI > 40) and/or body shape that might increase the risk of cutaneous burning from the Heckel hyperthermia device (because of truncal skin being too close to the infrared lights).

11. Any history of or current diagnosis of thrombosis or thrombophilia; if it is unclear whether a subject has received this diagnosis, a signed release will be obtained to contact the subject's treating physician and obtain accurate diagnostic information. Depending on the recommendation of the treating physician, the subject may undergo appropriate testing with the treating physician to verify the diagnosis, and if the tests produce negative findings, the subject may be allowed to enter the study

12. Has a history of or an increased risk for gastrointestinal perforation such as a history of diverticulitis, stomach or intestinal ulcers or abdominal pain that does not go away

13. Using medication that might impact thermoregulatory capacity within 3 days of receiving WBH treatment, including: diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose for prophylactic purposes), non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, or cytokine antagonists.

14. Use of any medication that could interact in such a way as to potentiate the sedative effect of lorazepam or ondansetron, or otherwise deemed unsafe per physician judgment.

15. Fever (Temp > 99) of unknown origin at the time of screen

16. Breast Implants

17. Unsafe cardiac status as defined by abnormal ECG reading at screening visit as determined by medical monitor, study doctor, or subject's primary care physician or cardiologist

18. Claustrophobia of sufficient severity to interfere with ability to enter/remain in Heckel device

19. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Simmie L. Foster, MD

Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital Depression Clinical & Research Program

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Simmie Foster, MD PhD

Role: CONTACT

sfoster4@partners.org

617-643-7427

Maren Nyer, PhD

Role: CONTACT

mnyer@mgh.harvard.edu

617-643-4897

Facility Contacts

Study Coordinator

Role: primary

mgh-wbh@partners.org

617-724-3222

Other Identifiers

5K23GM129630-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019P001103

Identifier Type: -

Identifier Source: org_study_id