The Brain on Whole Body Hyperthermia: A Neuroimaging Study

This is an interventional treatment trial for Major Depression focused on measuring Whole Body Hyperthermia, Functional Magnetic Resonance Imaging, EEG Read More

Inclusion Criteria:

• Male or female aged 18-30.
• Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
• Fluent English Speakers (for fMRI purposes)
• Right-handed (for fMRI purposes)
• For women of child-bearing potential (i.e., one who is biologically capable of becoming pregnant), must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial.
• Beck Depression Inventory-II Score of ≥14 (Moderate depression)
• Normal or corrected to normal vision and normal hearing (for fMRI purposes)

Exclusion Criteria:

• Any of the following diagnoses, as identified by the intake evaluation conducted or study assessments:
• A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device and/or the fMRI machine.
• A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
• A current (within 1 month prior to screening visit) diagnosis of substance dependence
• Lifetime history of schizophrenia or bipolar I disorder
• Use of psychotropic medications within 2 weeks of screening (8 weeks for fluoxetine) except for use of benzodiazepine or non-benzodiazepine sleeping agents
• Subject has a medical condition or disorder that:
• Is unstable and clinically significant, or:
• Could interfere with the accurate assessment of safety or efficacy of treatment, including:
• individuals who are using prescription drugs that may impair thermoregulatory cooling, including diuretics, barbiturates, and beta-blockers, or antihistamines,
• individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
• individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
• hemophiliacs/individuals prone to bleeding,
• individuals with a fever the day of study intervention,
• individuals with hypersensitivity to heat,
• individuals with recent acute joint injury,
• individuals with enclosed infections, be they dental, in joints, or in any other tissues,
• individuals with silicone or saline implants as these can overheat and lead to burning
• Clinically significant, in the investigator's opinion, abnormal findings on screening laboratory tests or physical exam as presented to the research team.
• Need for any non-protocol psychotropic medication once enrolled, with the exception of benzodiazepine or non-benzodiazepine hypnotics used at a stable dosage.
• Women who are pregnant (HCG pregnancy test at screening, or lactating, or who plan to become pregnant during the study.
• Current participation in any clinical trial that might impact results of this one, which includes participation in another clinical trial for depression, as well as drug trials with agents that might affect mood or regulation of body temperature.
• Reasonable likelihood for non-compliance with the protocol for any other reason, in the opinion of the Investigator, prohibits enrollment of subject into the study.
• Obesity and overall size of subject. It will be up to the PI's discretion will consider BMI, waist circumference, and body fat composition when determining eligibility and safety of the individual.
• History of peripheral circulatory disease, for example peripheral vascular disease, deep vein thrombosis (DVT), or lymphedema.
• History of a cerebral vascular accident
• History of stroke, epilepsy or cerebral aneurisms
• Cancer in the last five years.
• Diabetes mellitus types I or II
• Any clinically significant autoimmune disease (compensated hypothyroidism allowed)
• Any prior history of neurological disorder, traumatic brain injury associated with an alteration of consciousness, serious medical illness that could result in cognitive impairments, and drug or alcohol dependence.
• Any potential risks for MRI, including metal fragments, implants, pins or plates, pacemakers, or metal dental work.