Mild-Intensity Whole Body Hyperthermia (WBH) for Major Depressive Disorder (NCT03787290) | Clinical Trial Compass
SuspendedPhase 2
Mild-Intensity Whole Body Hyperthermia (WBH) for Major Depressive Disorder
Stopped: we were not able to get the study drug due to covid
United States35 participantsStarted 2026-12-01
Plain-language summary
Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to provide informed consent for study participation.
. Males and females between the age of 18 and 65 years.
. Have a current primary psychiatric diagnosis of major depressive disorder (MDD) of at least 4 weeks duration, as defined by DSM-5 criteria using the MINI v.7.0.
. A Screening and Baseline visit Clinician-Administered Inventory of Depressive Symptomatology Questionnaire (IDS-C30) score ≥ 25.
. Screening visit high-sensitivity C-reactive protein (CRP) concentration ≤ 5 mg/L (based on evidence that cytokine antagonism has an independent antidepressant effect in depressed patients with elevated CRP above this cut-off).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Inventory of Depressive Symptomatology Self-Report (IDS-SR)
. Any other medical condition that in the judgment of the PI would increase the risk of study participation or introduce excessive physiological variance into the study population
. A positive score to C-SSRS items 4 or 5 is OR a suicide attempt in the past 12 months
. Morbid obesity and/or body shape that might increase the risk of cutaneous burning from the Heckel HT3000 hyperthermia device (because of truncal skin being too close to the infrared lights defined as 3 inches or less)
. Breast implants (because these increase the risk of burning)
. Known hypersensitivity to hyperthermia and/or infrared exposure
. Evidence of sunburn at time of treatment intervention
. Use of any medication that might impact thermoregulatory capacity within 5 days of receiving WBH treatment, including: stimulants, diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose ASA for prophylactic purposes), non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, cytokine antagonists