Whole Body Hyperthermia and Major Depression (MDD)

Depressive Disorder, Major Clinical Trial

Official title: Whole Body Hyperthermia and Major Depression (MDD)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Fever

• NCT number: NCT01625546
• Study type: Interventional
• Source: University of Arizona
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Completion date: May 2015