Hyperthermia to see if it helps depression linked to inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, sham-controlled trial comparing whole-body hyperthermia (WBH) to a sham procedure in adults with Major Depressive Disorder. Participants will be screened and then randomized to receive one WBH or sham session, with follow-up assessments up to four weeks. Primary measures include changes in inflammatory proteins such as IL-6 in plasma at 1 hour, 24 hours, and 1 week post-treatment. The study also evaluates depression response, defined as a 50% or greater reduction in IDS-C scores at 7 days, 2 weeks, and 4 weeks after treatment. The trial aims to explore whether thermoinflammatory changes from WBH correlate with improvements in depressive symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital Depression Clinical & Research Program
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Simmie Foster, MD PhD
• Email: sfoster4@partners.org
• Phone: 617-643-7427

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.