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NCT02062840 · ClinicalTrials.gov registry record · NA
The Brain on Whole Body Hyperthermia: A Neuroimaging Study
A NA study of Major Depression, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT02062840 is a NA study of Major Depression that has completed, run by University of Arizona. The registered enrollment target is 23 participants, below the 327-participant average among 28 other Major Depression trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02062840, a NA study of Major Depression, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators have 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 have been shown in animals to be important for mood and body temperature regulation. Consistent with this known anatomy in our preliminary study in depressed patients, reductions in core body temperature were highly correlated with reductions in depressive symptoms over the same time period (one week post WBH). Moreover, patients with higher mean core body temperature prior to treatment had enhanced antidepressant effects. Because increased body temperature is an outcome of poor functioning in the skin-to-brain pathway activated by WBH our data suggests that WBH may actually sensitize this pathway in ways that promote changes in brain functioning known to promote emotional well-being. The results of our first open trial have encouraged us to conduct a larger, more rigorous placebo-controlled, double blind study of WBH for MDD, which is currently underway at the University of Arizona Medical School. Missing from our assessments in this ongoing double-blind study is any measure of the impact of WBH on brain function. The current proposal addresses ths gap in our investigative portfolio by proposing to conduct a second, randomized trial of active vs. sham WBH that will examine the impact of WBH on measures of brain function known from prior studies to be important for both depression and its treatment.
Conditions Studied
Interventions
- OTHER Questionnaires
- DEVICE High intensity whole-body infrared heating
- DEVICE Low intensity whole-body infrared heating
- DEVICE Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG)
Study Locations (1)
Arizona
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02062840
The ClinicalTrials.gov registry entry for NCT02062840 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 327-participant average among 28 other Major Depression trials with a reported enrollment target (93% lower). The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depression appearing as the primary indexed condition, and to 4 interventions - of which Questionnaires is the first listed.
NCT02062840 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT02062840 about?
NCT02062840 is a clinical study titled "The Brain on Whole Body Hyperthermia: A Neuroimaging Study". The investigators have 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 depressi...
What is the current status of trial NCT02062840?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2014-02. Estimated completion is 2015-05.
What conditions does trial NCT02062840 study?
This clinical trial studies the following conditions: Major Depression.
What interventions are being tested in trial NCT02062840?
The interventions under investigation include: Questionnaires (OTHER), High intensity whole-body infrared heating (DEVICE), Low intensity whole-body infrared heating (DEVICE), Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG) (DEVICE).
Who is sponsoring clinical trial NCT02062840?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02062840 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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