Actively Recruiting
Whole-body Hyperthermia for Depression
Led by University of Zurich · Updated on 2024-06-11
30
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test the efficacy of whole-body hyperthermia in major depression. The main question it aims to answer is: • Does whole-body hyperthermia alleviate symptoms of depression? Participants will be randomised to sham or active whole-body hyperthermia. The study will last 6 weeks during which five visits will take place. Depression will be measured repeatedly and biological mechanisms will be investigated.
CONDITIONS
Official Title
Whole-body Hyperthermia for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mental capacity to make decisions
- Signed informed consent
- Fluent in the German language
- Age between 18 and 65 years
- Pre-menopausal women willing to use birth control or refrain from sexual intercourse during the study if this matches their usual lifestyle
- Meet DSM-5 criteria for a major depressive episode
- Score of 14 or higher on the Hamilton Rating Scale for Depression (HAMD-17)
- Major depression is the primary mental disorder
You will not qualify if you...
- Vulnerable subjects
- Known or suspected non-compliance, drug or alcohol abuse within the past 2 years
- Inability to follow study procedures due to language problems, psychological disorders, dementia, or similar
- Participation in another investigational drug or medical device study within 30 days prior or during this study
- Previous enrollment in this study
- Enrollment of Sponsor-Investigator, family, employees, or dependents
- Contraindications or limitations of the medical device per instructions for use
- Body Mass Index (BMI) over 30
- Lifetime diagnosis of schizophrenia or bipolar disorder
- Current catatonic or psychotic symptoms
- Current suicidal thoughts
- Severe claustrophobia
- Anorexia or bulimia nervosa within the past 5 years
- Presence of metallic, silicone, or saline implants
- Cardiovascular problems including uncontrolled hypertension, congestive heart failure, or coronary artery disease
- Chronic diseases affecting thermoregulation such as Parkinson's, multiple sclerosis, CNS tumors, or diabetic neuropathy
- History of peripheral circulatory disease, deep vein thrombosis, cerebral vascular accident, epilepsy, or cerebral aneurysms
- Cancer diagnosis within the last 5 years except for removed non-melanoma skin cancer
- Clinically significant autoimmune diseases
- Hemophilia or bleeding tendency
- Fever on the day of study intervention
- Sensitivity to heat
- Recent acute joint injury
- Active infections including dental or joint infections
- Any unstable or clinically significant medical condition that could affect safety or study assessments
- Use of medications that interfere with thermoregulation such as barbiturates, diuretics, beta-blockers, or antihistamines
- Use of psychotropic medication within 2 weeks (8 weeks for fluoxetine)
- Need for psychotropic medication during the study
- Current psychotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Zurich, Institute of Psychology
Zurich, Switzerland, 8050
Actively Recruiting
Research Team
S
Susanne Fischer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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