Whole Body Hyperthermia and Major Depression (MDD)

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.