The Brain on Whole Body Hyperthermia: A Neuroimaging Study

Completed · Not applicable

Conditions studied: Major Depression

In brief

The investigators have observed in an open trial that a single session of whole body hyperthermia (WBH) induced rapid antidepressant effects that persisted for at least a week in patients with major depression (MDD) severe enough to warrant inpatient hospitalization. In addition to reducing depression, the single session of WBH induced a prolonged reduction in mean core body temperature, consistent with basic science data from our group suggesting that hyperthermia activates a skin-to-brain pathway that have been shown in animals to be important for mood and body temperature regulation. Consistent with this known anatomy in our preliminary study in depressed patients, reductions in core body temperature were highly correlated with reductions in depressive symptoms over the same time period (one week post WBH). Moreover, patients with higher mean core body temperature prior to treatment had enhanced antidepressant effects. Because increased body temperature is an outcome of poor functioning in the skin-to-brain pathway activated by WBH our data suggests that WBH may actually sensitize this pathway in ways that promote changes in brain functioning known to promote emotional well-being. The results of our first open trial have encouraged us to conduct a larger, more rigorous placebo-controlled, double blind study of WBH for MDD, which is currently underway at the University of Arizona Medical School. Missing from our assessments in this ongoing double-blind study is any measure of the impact of WBH on brain function. The current proposal addresses ths gap in our investigative portfolio by proposing to conduct a second, randomized trial of active vs. sham WBH that will examine the impact of WBH on measures of brain function known from prior studies to be important for both depression and its treatment.

Key facts

Study ID: NCT02062840
Run by: University of Arizona
People needed: 23
Starts: 2014-02-01
Expected to finish: 2015-05-01
Last updated by the study team: 2015-08-10

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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