Whole Body Hyperthermia and Major Depression (MDD)
- Conditions
- Depressive Disorder, Major
- Interventions
- Device: Whole Body Hyperthermia system
- Registration Number
- NCT01625546
- Lead Sponsor
- University of Arizona
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High intensity whole-body infrared heating Whole Body Hyperthermia system Subjects will be induced to levels of heat that increases core body temperature to approximately 37.5-38.5 °C using the Whole Body Hyperthermia system. Low intensity whole-body infrared heating Whole Body Hyperthermia system Subjects will be induced to levels of heat that causes only a minor increase in body temperature using Whole Body Hyperthermia system.
- Primary Outcome Measures
Name Time Method 17-item Hamilton Rating Scale for Depression (HAM-D; derived from the 31-item instrument) Screening, at intervention, and at weeks 1, 2, 4 and 6 following the intervention. Additionally, at the open treatment, 1 week following the open treatment and at the 3-month follow up. To determine acute and sustained effects of Whole Body Hyperthermia (WBH) on depression severity.
- Secondary Outcome Measures
Name Time Method Sleep assessment 3 days (over the weekend) at baseline, week 1 and week 4. To assess how the WBH affects sleep, participants will be given an actigraph to wear on their non-dominant wrist over three days and nights during the weekend assessments at baseline, post-intervention week 1 and study week 4. They will also be instructed to complete a daily sleep diary during the time they wear the sleep watch.
Core body temperature monitoring 3 days (over the weekend) at baseline, week 1 and week 4. Body temperature will be measured with a Vitalsense unit (Minimitter Respironics, Bend OR). The Vitalsense system includes easy to swallow telemetric capsules about the size of a multivitamin (dimensions 23 cm x 8.7 mm) made of medical grade plastic (biocompatible polycarbonate). After ingestion, pills normally pass between 1 to 5 days (mean 2 ± 1.5 days) and then are discarded. A second pill will be ingested if the pill passes during the study visit. Pill temperature sensors transmit data to a small, battery operated, lightweight, user-worn device that may be worn on a belt or placed in a pocket (Dimensions 120 x 90 x 25 mm; weight 200 grams). The devise can collect up to 10 channels for 240 h without battery replacement or download.
Skin conductance level On the day of the WBH or control treatment, and at one and 4 weeks following the control/intervention. Thermoregulatory cooling will be assessed by 1) skin conductance level (SCL) following the protocol outlined by Ward et al
Heart Rate Variability On the day of the WBH or control treatment, and at one and 4 weeks following the control/intervention. Heart Rate Variability (HRV) will be assessed during the period of SCL collection and will be calculated using both time and frequency domain methodologies.
EAR Assessment 3 days (over the weekend) at baseline, week 1 and week 4. 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).
Plasma Concentrations of Biological Predictors of Response and Mechanism of Action for WBH. Prior to WBH or control, following WBH or control, and at Week 1 and Week 4 follow-up visits. Blood samples will be analyzed for physiological measures expected to be impacted by WBH including RNA expression, plasma concentrations of BDNF, and pro- and anti-inflammatory cytokines.
QIDS = Quick Inventory of Depressive Symptoms Screening, baseline, WBH intervention day, once during the three days following the intervention, and at Week 1, 2, 4 and 6 following intervention. Additionally at the open treatment, 1 week following the open treatment and at the 3-month follow up. To determine effects of Whole Body Hyperthermia (WBH) on depressive symptoms.
Change in QIDS (Quick Inventory of Depressive Symptoms) Score from baseline response Screening, at intervention, and at weeks 1, 2, 4 and 6 following the intervention. Additionally, at the open treatment, 1 week following the open treatment and at the 3-month follow up.
Trial Locations
- Locations (1)
University of Arizona
🇺🇸Tucson, Arizona, United States