Peripheral Neuroimmune Mechanisms of Hyperthermia

Last updated: March 8, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Depression

Depression (Adult And Geriatric)

Treatment

N/A

Clinical Study ID

NCT05366270
2019P001103
5K23GM129630-03
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atleast 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

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 RatingScale)
  5. History of bipolar disorder, psychotic disorders, eating disorders, and/or substanceabuse or dependence (within the last year), as per the Mini-InternationalNeuropsychiatric 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 exclusionarymedications. (Potential false positives will be addressed on a case-by-case basis atthe 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 cutaneousburning from the Heckel hyperthermia device (because of truncal skin being too closeto the infrared lights).
  11. Any history of or current diagnosis of thrombosis or thrombophilia; if it is unclearwhether a subject has received this diagnosis, a signed release will be obtained tocontact the subject's treating physician and obtain accurate diagnostic information.Depending on the recommendation of the treating physician, the subject may undergoappropriate testing with the treating physician to verify the diagnosis, and if thetests 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 ahistory of diverticulitis, stomach or intestinal ulcers or abdominal pain that doesnot go away
  13. Using medication that might impact thermoregulatory capacity within 3 days ofreceiving 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-steroidalanti-inflammatory drugs (NSAIDs), systemic corticosteroids, or cytokine antagonists.
  14. Use of any medication that could interact in such a way as to potentiate the sedativeeffect 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 asdetermined by medical monitor, study doctor, or subject's primary care physician orcardiologist
  18. Claustrophobia of sufficient severity to interfere with ability to enter/remain inHeckel device
  19. A subject who in the opinion of the Principal Investigator would not be able to safelycomplete the study or would jeopardize study integrity

Study Design

Total Participants: 60
Study Start date:
November 01, 2022
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Massachusetts General Hospital Depression Clinical & Research Program

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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