Enhancing Psychotherapy for Mood Disorders With Whole Body Hyperthermia

Launched by CHARLES (CHUCK) RAISON · Dec 19, 2013

Keywords

ClinConnect Summary

Our research group has 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 targets specific serotonergic nuclei in the raphe. In animal models, these nuclei have b...

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Eligibility criteria

• Inclusion Criteria for Psychotherapy and Questionnaire Group:
• • - The only inclusion criteria for this group is that they are deemed eligible to receive psychotherapy at the Psychology Department Clinic, are fluent in English and are interested in participating in the study. There are no specific exclusion criteria for this study group.
• Inclusion Criteria for WBH Psychotherapy Group:
• • Male or female outpatients aged 18-65.
• • Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
• • Able to communicate in English with study personnel.
• • 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.
• 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
• • A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
• * 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,
• • Clinically significant, in the investigator's opinion, abnormal findings on screening laboratory tests or physical exam as presented to the research team.
• • Use of any psychotropic medications for 2 weeks (8 weeks for fluoxetine) prior to initiation of the study, with the exception of hypnotic medications (zolpidem, zaleplon, eszopiclone).
• • Need for any non-protocol psychotropic medication during the trial, with the exception of hypnotics used up to four nights per week.
• • 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)