Major DepressionNCT02062840
The Brain on Whole Body Hyperthermia: A Neuroimaging Study
A study testing High intensity whole-body infrared heating, Low intensity whole-body infrared heating and Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG) in people with Major Depression, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- High intensity whole-body infrared heating, Low intensity whole-body infrared heating and Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18-30.
- Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
- Fluent English Speakers (for fMRI purposes)
- Right-handed (for fMRI purposes)
- For women of child-bearing potential (i.e., one who is biologically capable of becoming pregnant), must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial.
- Beck Depression Inventory-II Score of ≥14 (Moderate depression)
- Normal or corrected to normal vision and normal hearing (for fMRI purposes)
Who cannot join
- Any of the following diagnoses, as identified by the intake evaluation conducted or study assessments:
- A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device and/or the fMRI machine.
- A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
- A current (within 1 month prior to screening visit) diagnosis of substance dependence
- Lifetime history of schizophrenia or bipolar I disorder
- Use of psychotropic medications within 2 weeks of screening (8 weeks for fluoxetine) except for use of benzodiazepine or non-benzodiazepine sleeping agents
Show all 32Show fewer
- Subject has a medical condition or disorder that:
- Is unstable and clinically significant, or:
- Could interfere with the accurate assessment of safety or efficacy of treatment, including:
- individuals who are using prescription drugs that may impair thermoregulatory cooling, including diuretics, barbiturates, and beta-blockers, or antihistamines,
- individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
- individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
- hemophiliacs/individuals prone to bleeding,
- individuals with a fever the day of study intervention,
- individuals with hypersensitivity to heat,
- individuals with recent acute joint injury,
- individuals with enclosed infections, be they dental, in joints, or in any other tissues,
- individuals with silicone or saline implants as these can overheat and lead to burning
- Clinically significant, in the investigator's opinion, abnormal findings on screening laboratory tests or physical exam as presented to the research team.
- Need for any non-protocol psychotropic medication once enrolled, with the exception of benzodiazepine or non-benzodiazepine hypnotics used at a stable dosage.
- Women who are pregnant (HCG pregnancy test at screening, or lactating, or who plan to become pregnant during the study.
- Current participation in any clinical trial that might impact results of this one, which includes participation in another clinical trial for depression, as well as drug trials with agents that might affect mood or regulation of body temperature.
- Reasonable likelihood for non-compliance with the protocol for any other reason, in the opinion of the Investigator, prohibits enrollment of subject into the study.
- Obesity and overall size of subject. It will be up to the PI's discretion will consider BMI, waist circumference, and body fat composition when determining eligibility and safety of the individual.
- History of peripheral circulatory disease, for example peripheral vascular disease, deep vein thrombosis (DVT), or lymphedema.
- History of a cerebral vascular accident
- History of stroke, epilepsy or cerebral aneurisms
- Cancer in the last five years.
- Diabetes mellitus types I or II
- Any clinically significant autoimmune disease (compensated hypothyroidism allowed)
- Any prior history of neurological disorder, traumatic brain injury associated with an alteration of consciousness, serious medical illness that could result in cognitive impairments, and drug or alcohol dependence.
- Any potential risks for MRI, including metal fragments, implants, pins or plates, pacemakers, or metal dental work.
Trial locations and contacts
1 site in 1 country.
About this 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 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.
Read the detailed description
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 targets specific serotonergic nuclei in the raphe. In animal models, these nuclei have been shown to be important for mood and body temperature regultion. 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 suggest 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. In addition to assessing effects on depressive symptoms in comparison to a sham condition, this study examines the effect of WBH on body temperature, autonomic nervous system function, thermoregulatory cooling, immune, neuroendocrine and monoamine functioning and real-world daily social behavior.
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. These measures will include functional magnetic resonance imaging (fMRI) analyses of resting state brain connectivity as well as assessments of concordance between subgenual anterior cingulate cortex and autonomic nervous system function assessed by electrocardiogram (EKG). Prior to these fMRI assessments a structural MRI will be obtained.
The investigators propose to conduct this fMRI/EKGtudy in 30 students (15 males/15 females) recruited from the PSYC150A1 Mass survey, which allows University of Arizona students an opportunity to serve as research subjects for course credit. These potential participants will be between the ages of 18 and 30 and will have self-reported depressive symptomatology of at least moderate severity, as reflected in a Beck Depression Inventory (BDI) II score ≥ 14. Participants will be medically healthy with no history of bipolar I disorder, schizophrenia or active substance dependence. Participants will complete questionnaires one week prior to, the day of, and one week following a single administration of either WBH or sham WBH (delivered with a 1-to-1 ratio). On the morning prior receiving WBH or sham WBH and again 24 hours later all subjects will undergo fMRI/EKG assessment. This design will allow us to evaluate the acute brain effects of WBH and to evaluate the relationship between these changes and both acute and short term (i.e. one week post treatment) improvements in mood.
- Conditions
- Major Depression
- Being tested
- High intensity whole-body infrared heating, Low intensity whole-body infrared heating, Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG), Questionnaires
- Keywords
- Whole Body Hyperthermia, Functional Magnetic Resonance Imaging, EEG
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity whole-body infrared heatingDevice
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. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.
Low intensity whole-body infrared heatingDevice
Attenuated heating using only heating coils at the bottom of the Heckel device. This results in only a minor increase in skin temperature and no increase in core body temperature. The participant will still feel heat and will see similar lighting and hear similar sounds as those occurring during actual WBH, and will be in the chamber for the same period of time.
Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG)Device
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain. An standard EKG (compatible with the fMRI machine) will be used to take measurements of cardiac vagal control.
QuestionnairesOther
Weekly questionnaires to assess changes in depression, mood, perceptions of self and quality of life will be administered.
| Study group | Role | What they receive |
|---|---|---|
| High intensity whole-body infrared heating and Neuroimaging | Experimental | Subjects will have an fMRI the morning of their WBH session and and fill out study questionnaires. Following the fMRI session, the participant will undergo the WBH intervention where subjects will be induced to levels of heat that increases core body temperature to approximately 37.5-38.5 °C.temperature. Receives: Device: High intensity whole-body infrared heating; Device: Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG); Other: Questionnaires |
| Low intensity whole-body infrared heating and | Sham comparator | Subjects will have an fMRI the morning of their WBH session and and fill out study questionnaires. Following the fMRI session, the participant will undergo the WBH-control intervention where subjects will be induced to levels of heat that causes only a minor increase in body temperature. Receives: Device: Low intensity whole-body infrared heating; Device: Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG); Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute brain effects of WBH on resting state brain connectivity and function
Functional magnetic resonance imaging (fMRI) analyses of resting state brain connectivity.
Measured: Change from baseline in resting state brain connectivity and one day following WBH/WBH-control Treatment.
Degree of concordance of brain activity with autonomic nervous system function
Functional magnetic resonance imaging (fMRI) analyses of concordance between subgenual anterior cingulate cortex and autonomic nervous system function assessed by electrocardiogram (EKG). The investigators are specifically looking at the inter-relationship between cardiac vagal control and brain activity.
Measured: Change from baseline in concordance between subgenual anteriori cingulate cortex and autonomic nervous system function and one day following WBH/WBH-control Treatment.
Secondary outcomes (4)
Change in depression scores over time.
Percent change in scores between baseline and subsequent assessments will be assessed using the Beck Depression Inventory (BDI).
Measured: Seven days prior to WBH/WBH-control treatment, the day of and two days immediately following WBH/WBH-control treatment, and 7 days following WBH/WBH-control treatment.
Change in Positive and Negative Affect
Percent change in positive and negative affect will be assessed between baseline and subsequent assessments using the Positive and Negative Affect Schedule (PANAS)
Measured: Seven days prior to WBH/WBH-control treatment, the day of and two days immediately following WBH/WBH-control treatment, and 7 days follwoing WBH/WBH-control treatment.
Change in ability to function in daily life
Percent change in scores between baseline and subsequent assessments will be assessed the Sheehan Disability Scale (SDS).
Measured: Seven days prior to WBH/WBH-control treatment, the day of and two days immediately following WBH/WBH-control treatment, and 7 days following WBH/WBH-control treatment.
Change in quality of life
Percent change in scores between baseline and subsequent assessments will be assessed using the Quality of Life and Enjoyment Scale (Q-LES).
Measured: Seven days prior to WBH/WBH-control treatment, the day of and two days immediately following WBH/WBH-control treatment, and 7 days following WBH/WBH-control treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles (Chuck) Raison, University of Arizona
- Investigators
- Charles Raison, MD, Principal investigator, University of Arizona, Department of Psychiatry, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062840
- Sponsor's protocol ID
- 13-121-670-10
- Status last verified
- Aug 2015
- First submitted
- 7 Feb 2014
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brain on Whole Body Hyperthermia: A Neuroimaging Study
- ClinicalTrials.gov ID
- NCT02062840
- Acronym / sponsor ID
- 13-121-670-10
- Conditions
- Major Depression
- Keywords
- Whole Body Hyperthermia, Functional Magnetic Resonance Imaging, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 targets specific serotonergic nuclei in the raphe. In animal models, these nuclei have been shown to be important for mood and body temperature regultion. 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 suggest 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. In addition to assessing effects on depressive symptoms in comparison to a sham condition, this study examines the effect of WBH on body temperature, autonomic nervous system function, thermoregulatory cooling, immune, neuroendocrine and monoamine functioning and real-world daily social behavior.
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. These measures will include functional magnetic resonance imaging (fMRI) analyses of resting state brain connectivity as well as assessments of concordance between subgenual anterior cingulate cortex and autonomic nervous system function assessed by electrocardiogram (EKG). Prior to these fMRI assessments a structural MRI will be obtained.
The investigators propose to conduct this fMRI/EKGtudy in 30 students (15 males/15 females) recruited from the PSYC150A1 Mass survey, which allows University of Arizona students an opportunity to serve as research subjects for course credit. These potential participants will be between the ages of 18 and 30 and will have self-reported depressive symptomatology of at least moderate severity, as reflected in a Beck Depression Inventory (BDI) II score ≥ 14. Participants will be medically healthy with no history of bipolar I disorder, schizophrenia or active substance dependence. Participants will complete questionnaires one week prior to, the day of, and one week following a single administration of either WBH or sham WBH (delivered with a 1-to-1 ratio). On the morning prior receiving WBH or sham WBH and again 24 hours later all subjects will undergo fMRI/EKG assessment. This design will allow us to evaluate the acute brain effects of WBH and to evaluate the relationship between these changes and both acute and short term (i.e. one week post treatment) improvements in mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity whole-body infrared heating and Neuroimaging | Experimental | Device: High intensity whole-body infrared heating, Device: Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG), Other: QuestionnairesSubjects will have an fMRI the morning of their WBH session and and fill out study questionnaires. Following the fMRI session, the participant will undergo the WBH intervention where subjects will be induced to levels of heat that increases core body temperature to approximately 37.5-38.5 °C.temperature. |
| Low intensity whole-body infrared heating and | Sham comparator | Device: Low intensity whole-body infrared heating, Device: Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG), Other: QuestionnairesSubjects will have an fMRI the morning of their WBH session and and fill out study questionnaires. Following the fMRI session, the participant will undergo the WBH-control intervention where subjects will be induced to levels of heat that causes only a minor increase in body temperature. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female aged 18-30.
- Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
- Fluent English Speakers (for fMRI purposes)
- Right-handed (for fMRI purposes)
- For women of child-bearing potential (i.e., one who is biologically capable of becoming pregnant), must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial.
Key exclusion criteria (32 listed)
- Any of the following diagnoses, as identified by the intake evaluation conducted or study assessments:
- A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device and/or the fMRI machine.
- A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
- A current (within 1 month prior to screening visit) diagnosis of substance dependence
- Lifetime history of schizophrenia or bipolar I disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity whole-body infrared heatingThe 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. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C. | Device | High intensity whole-body infrared heating and Neuroimaging |
| Low intensity whole-body infrared heatingAttenuated heating using only heating coils at the bottom of the Heckel device. This results in only a minor increase in skin temperature and no increase in core body temperature. The participant will still feel heat and will see similar lighting and hear similar sounds as those occurring during actual WBH, and will be in the chamber for the same period of time. | Device | Low intensity whole-body infrared heating and |
| Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG)A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain. An standard EKG (compatible with the fMRI machine) will be used to take measurements of cardiac vagal control. | Device | High intensity whole-body infrared heating and Neuroimaging, Low intensity whole-body infrared heating and |
| QuestionnairesWeekly questionnaires to assess changes in depression, mood, perceptions of self and quality of life will be administered. | Other | High intensity whole-body infrared heating and Neuroimaging, Low intensity whole-body infrared heating and |
Primary outcome
Change in acute brain effects of WBH on resting state brain connectivity and function
Time frame: Change from baseline in resting state brain connectivity and one day following WBH/WBH-control Treatment.
Functional magnetic resonance imaging (fMRI) analyses of resting state brain connectivity.
Degree of concordance of brain activity with autonomic nervous system function
Time frame: Change from baseline in concordance between subgenual anteriori cingulate cortex and autonomic nervous system function and one day following WBH/WBH-control Treatment.
Functional magnetic resonance imaging (fMRI) analyses of concordance between subgenual anterior cingulate cortex and autonomic nervous system function assessed by electrocardiogram (EKG). The investigators are specifically looking at the inter-relationship between cardiac vagal control and brain activity.
4 secondary outcomes
Change in depression scores over time.
Time frame: Seven days prior to WBH/WBH-control treatment, the day of and two days immediately following WBH/WBH-control treatment, and 7 days following WBH/WBH-control treatment.
Change in Positive and Negative Affect
Time frame: Seven days prior to WBH/WBH-control treatment, the day of and two days immediately following WBH/WBH-control treatment, and 7 days follwoing WBH/WBH-control treatment.
Change in ability to function in daily life
Time frame: Seven days prior to WBH/WBH-control treatment, the day of and two days immediately following WBH/WBH-control treatment, and 7 days following WBH/WBH-control treatment.
Change in quality of life
Time frame: Seven days prior to WBH/WBH-control treatment, the day of and two days immediately following WBH/WBH-control treatment, and 7 days following WBH/WBH-control treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Raison, MD principal investigator
University of Arizona, Department of Psychiatry, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity whole-body infrared heating, Low intensity whole-body infrared heating and Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG) in people with Major Depression, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acute brain effects of WBH on resting state brain connectivity and function (time frame: Change from baseline in resting state brain connectivity and one day following WBH/WBH-control Treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.