Whole Body Hyperthermia and Major Depression (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Hyperthermia; Fever; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Major depressive disorder (MDD) is predicted to be the second leading cause of disability
      worldwide by the year 2020. The economic burden of depression in the United States is
      significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high
      rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD
      patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients
      will fail to adequately respond to all currently available interventions. Moreover, current
      treatments come at the cost of significant central nervous system (CNS) side effects, further
      highlighting the need for more effective treatments with fewer side effects. This study will
      compare temperature ranges from the investigators preliminary studies involving
      thermoafferent pathways resulting in antidepressant actions with lower temperature ranges not
      expected to activate these pathways as a control condition, with the goal to evaluate whether
      previous observations were related to the temperature range in question or can be achieved
      with other levels.
    

Detailed description: 
      We will conduct a placebo controlled clinical trial to determine if Whole Body Hyperthermia
      has antidepressant effects in medically healthy patients with moderate to severe MDD. We plan
      to recruit a sample of 30 medically healthy individuals with MDD who will be randomized to
      examine whether WBH will demonstrate an antidepressant effect when compared to a control-WBH
      condition that will be comprised of very mild heating in the WBH machine (Heckel HT3000). To
      determine acute and sustained effects of WBH on depression severity, the study will include
      basic clinical and psychiatric assessments 5 days before and after WBH and follow-up
      assessments at 2, 4, and 6 weeks following WBH. Additionally, assessments will be conducted
      during the optional open treatment, 1 week following the open treatment, and at the 3 month
      follow up. To assess whether WBH affects how individuals relate to other people in their
      environment, as well as how they spend their time in general and to assess social processes,
      the study will employ the Electronically Activated Recorder (EAR). Participants will wear the
      EAR device during the day, while going about their lives over the weekend. This weekend
      monitoring also includes an actigraphy assessment during which participants will wear an
      actigraphy device during their waking and sleeping hours. In addition, blood will be obtained
      at multiple time points to assess plasma concentrations of biological predictors or response
      and mechanism of action for WBH. This study challenges the existing paradigm by determining
      if peripheral afferent sensory pathways can be accessed to treat MDD and thus avoid problems
      of exposing all of the brain to non-selective drugs.
    

Intervention name(s): Whole Body Hyperthermia system
Intervention type(s): Device
Intervention description(s): The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Whole Body Hyperthermia