Peripheral Neuroimmune Mechanisms of Hyperthermia

Exclusion Criteria19

• 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)
• 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)
• 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
• 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
• Claustrophobia of sufficient severity to interfere with ability to enter/remain in Heckel device
• A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity