Whole-body Hyperthermia for Depression

University of Zurich (UZH)

Status

Enrolling

Conditions

Major Depressive Disorder

Treatments

Device: Active whole-body hyperthermia

Device: Sham whole-body hyperthermia

Study type

Interventional

Funder types

Other

Identifiers

NCT06323785

2022-D0067

Details and patient eligibility

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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