Peripheral Neuroimmune Mechanisms of Hyperthermia

NCT05366270 | Unknown DMC FDA Device

• 2 other identifiers: 2019P0011035K23GM129630-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperthermia; Major Depressive Disorder; Inflammation

Keywords

Depression; Major Depressive Disorder; Inflammation; Hyperthermia; Mood Disorders

Outcome Measures

Primary Outcomes (3)

• Changes in serum levels of Interleukin-6 from baseline to post-treatment

  Changes in serum levels of Interleukin-6 from baseline to post-treatment, measured by immunoassay

  baseline (pre-intervention), one hour post-intervention, 24 hours post-intervention, one week post-intervention

• Decreases in depressive severity, as measured by the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-CR)

  The Inventory of Depressive Symptomatology is a valid and reliable 30-item measure that is designed to assess severity of depression. The questions focus on neurovegetative and other depressive symptoms experienced over the past seven days. Possible values range from 0 to 84, with lower scores indicating lower depressive severity. A decrease of 50% or more in the IDS-CR score is considered to be a positive response to treatment, while a final score of 11 or less is considered typical remission. Depressive severity will be measured at baseline and at three timepoints post-intervention using the IDS-CR.

  baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

• Decreases in depressive severity, as measured by the Symptoms of Depression Questionnaire (SDQ)

  The Symptoms of Depression Questionnaire (SDQ) assesses irritability, anger attacks, and anxiety symptoms together with the commonly considered symptoms of depression. Depressive severity will be measured at baseline and at four timepoints post-intervention using the SDQ. Possible values range from 44 to 264, with lower scores indicating lower depressive severity.

  baseline (pre-intervention), 24 hours post-intervention, one week post-intervention, two weeks post-intervention, four weeks post-intervention

Secondary Outcomes (6)

• Changes in mental and physical functioning, as measured by the Patient Rated Outcome Measure Information System, 29-Item (PROMIS-29)

  baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

• Changes in mood, as measured by the Positive and Negative Affect Schedule (PANAS)

  baseline (pre-intervention), 24 hours post-intervention, one week post-intervention, two weeks post-intervention, four weeks post-intervention

• Changes to quality of life, as measured by the World Health Organization Wellbeing Index (WHO-5)

  baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

• Changes to quality of life, as measured by the Quality of Life, Enjoyment, and Satisfaction Questionnaire

  baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

• Reduction in perceived stress, as measured by the Perceived Stress Scale (PSS)

  baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

Study Arms (2)

Whole Body Hyperthermia (WBH)

EXPERIMENTAL

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.

Device: WBH

Sham

SHAM COMPARATOR

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.

Device: Sham

Interventions

WBH DEVICE

Hyperthermia exposure using Heckel Hyperthermia Device

Also known as: Whole Body Hyperthermia

Whole Body Hyperthermia (WBH)

Sham DEVICE

Sham (mild heating) using Heckel Hyperthermia Device

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and Males ages 18-65
• English language proficiency
• Ability to provide informed consent
• 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.
• Score of ≥ 24 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
• Individuals of childbearing potential must use an acceptable form of birth control.

You may not qualify if:

• Pregnancy or planned pregnancy during study
• Current breastfeeding
• History of psychiatric hospitalization within the past year
• Active suicidal intent ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)
• 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)
• Meeting DSM-5 criteria at screening for current obsessive compulsive disorder
• A ≥25% drop in IDS-CR score from screen (V1) to baseline (V1b)
• Serious unstable medical condition including cardiovascular, neurological, neoplastic, autoimmune, infectious or endocrine.
• 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).
• 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
• 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
• 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.
• 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.
• Fever (Temp \> 99) of unknown origin at the time of screen
• Breast Implants

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Massachusetts General Hospital Depression Clinical & Research Program

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Hyperthermia; Depressive Disorder, Major; Inflammation; Depression; Mood Disorders

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Depressive Disorder; Mental Disorders; Pathologic Processes; Behavioral Symptoms; Behavior

Central Study Contacts

Simmie Foster, MD PhD

CONTACT

617-643-7427; sfoster4@partners.org

Maren Nyer, PhD

CONTACT

617-643-4897; mnyer@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant and clinician assessors will be blinded until study completion. The PI will only be unblinded in the event of an adverse event.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Model Details: Subjects are randomized to Control/Sham and Intervention groups

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 9, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)