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New treatment option for Hyperthermia
Official title Peripheral Neuroimmune Mechanisms of Hyperthermia
ClinicalTrials.gov ID: NCT05366270
What this study is testing
- What it's testing
- The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Females and Males ages 18-65
- English language proficiency
- Ability to provide informed consent
- Have a current primary psychiatric diagnosis of major depressive disorder (MDD) of at least 4 weeks duration, as defined by Diagnostic \& Statistical...
- Score of ≥ 24 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
You likely can't join if
- Pregnancy or planned pregnancy during study
- Current breastfeeding
- History of psychiatric hospitalization within the past year
- Active suicidal intent ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)
- History of bipolar disorder, psychotic disorders, eating disorders, and/or substance abuse or dependence (within the last year), as per the...
- Meeting DSM-5 criteria at screening for current obsessive compulsive disorder
See the full eligibility criteria
- Females and Males ages 18-65
- English language proficiency
- Ability to provide informed consent
- Have a current primary psychiatric diagnosis of major depressive disorder (MDD) of at least 4 weeks duration, as defined by Diagnostic \& Statistical Manual, 5th Edition (DSM-5) criteria using the MINI.
- Score of ≥ 24 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
- Individuals of childbearing potential must use an acceptable form of birth control.
- Pregnancy or planned pregnancy during study
- Current breastfeeding
- History of psychiatric hospitalization within the past year
- Active suicidal intent ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)
- History of bipolar disorder, psychotic disorders, eating disorders, and/or substance abuse or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI)
- Meeting DSM-5 criteria at screening for current obsessive compulsive disorder
- A ≥25% drop in IDS-CR score from screen (V1) to baseline (V1b)
- Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the investigator)
- Serious unstable medical condition including cardiovascular, neurological, neoplastic, autoimmune, infectious or endocrine.
- Morbid obesity (BMI \> 40) and/or body shape that might increase the risk of cutaneous burning from the Heckel hyperthermia device (because of truncal skin being too close to the infrared lights).
- Any history of or current diagnosis of thrombosis or thrombophilia; if it is unclear whether a subject has received this diagnosis, a signed release will be obtained to contact the subject's treating physician and...
- Has a history of or an increased risk for gastrointestinal perforation such as a history of diverticulitis, stomach or intestinal ulcers or abdominal pain that does not go away
- Using medication that might impact thermoregulatory capacity within 3 days of receiving WBH treatment, including: diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of...
- Use of any medication that could interact in such a way as to potentiate the sedative effect of lorazepam or ondansetron, or otherwise deemed unsafe per physician judgment.
- Fever (Temp \> 99) of unknown origin at the time of screen
- Breast Implants
- Unsafe cardiac status as defined by abnormal ECG reading at screening visit as determined by medical monitor, study doctor, or subject's primary care physician or cardiologist
- Claustrophobia of sufficient severity to interfere with ability to enter/remain in Heckel device
- A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.