Whole-body Hyperthermia for Depression

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 sexualintercourse for the duration of the study (the latter only in the case that thiscorresponds 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 languageproblems, psychological disorders, dementia, etc. of the subject

• participation in another investigation with an investigational drug or another MDwithin 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 otherdependent persons

• contraindications and limitations of the MD as described in the instructions for use

• BMI > 30

• lifetime schizophrenia, lifetime bipolar disorder, current catatonic or psychoticsymptoms, current suicidal ideation, current severe claustrophobia, anorexia orbulimia 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 initiatethermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervoussystem tumors, and diabetes with neuropathy

• history of peripheral circulatory disease, including peripheral vascular disease anddeep 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 oftreatment

• intake of medication interfering with thermoregulatory cooling, includingbarbiturates, 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