Using whole-body hyperthermia to treat depression
Randomised Sham-controlled Trial of Whole-body Hyperthermia for Depression
This study is testing if whole-body heat therapy can help people with major depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06323785 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of whole-body hyperthermia in alleviating symptoms of major depressive disorder. Participants will be randomly assigned to receive either active whole-body hyperthermia or a sham treatment over a period of six weeks, with five scheduled visits. Throughout the study, depression levels will be assessed repeatedly, and the biological mechanisms underlying any observed effects will be investigated.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who meet the DSM-5 criteria for a major depressive episode and have a Hamilton Rating Scale for Depression score of 14 or higher.
Not a fit: Patients with other primary mental disorders or those who are vulnerable or unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from major depressive disorder.
How similar studies have performed: While the use of hyperthermia in treating depression is a relatively novel approach, there have been some preliminary studies suggesting potential benefits, though further research is needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * mental capacity to make decisions * informed consent signed by the subject * fluent in the German language * 18-65 years of age * pre-menopausal women: willing to use birth control or not to engage in sexual intercourse for the duration of the study (the latter only in the case that this corresponds to the habitual lifestyle of this person) * fulfil DSM-5 criteria for a major depressive episode * score ≥ 14 on the Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression) * the major depression is the primary mental disorder Exclusion Criteria: * vulnerable subjects * known or suspected non-compliance, drug or alcohol abuse within the past 2 years * inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject * participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation * previous enrolment into the current investigation * enrolment of the Sponsor-Investigator, her family members, employees and other dependent persons * contraindications and limitations of the MD as described in the instructions for use * BMI \> 30 * lifetime schizophrenia, lifetime bipolar disorder, current catatonic or psychotic symptoms, current suicidal ideation, current severe claustrophobia, anorexia or bulimia nervosa within the past 5 years * metallic, silicone, or saline implants * cardiovascular conditions or problems, including uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease * chronic conditions/diseases associated with a reduced ability to initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy * history of peripheral circulatory disease, including peripheral vascular disease and deep vein thrombosis * history of a cerebral vascular accident * history of epilepsy or cerebral aneurisms * cancer in the last five years, except for resected non-melanoma skin cancer * any clinically significant autoimmune disease * hemophilia or proneness to bleeding * fever the day of study intervention * hypersensitivity to heat * recent acute joint injury * enclosed infections, be they dental, in joints, or in any other tissues * any other medical condition or disorder that is unstable and clinically significant, or that could interfere with the accurate assessment of safety or efficacy of treatment * intake of medication interfering with thermoregulatory cooling, including barbiturates, diuretics, beta-blockers, and anti-histamines * intake of psychotropic medication within 2 weeks (8 weeks for fluoxetine) * need for psychotropic medication during the study period * current psychotherapy
Where this trial is running
Zurich
- University of Zurich, Institute of Psychology — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Susanne Fischer, PhD — University of Zurich
- Study coordinator: Susanne Fischer, PhD
- Email: s.fischer@psychologie.uzh.ch
- Phone: +41446357460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.