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 range18 Years – 65 Years
SexALL
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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
✕. Any of the following medical conditions:
✕. 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
What they're measuring
1
Inventory of Depressive Symptomatology Self-Report (IDS-SR)
✕. 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