Whole-body Hyperthermia for Depression

NCT06323785 | Recruiting

• 1 other identifier: 2022-D0067
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression)

  Depressive symptoms (observer-rated)

  1 week

Secondary Outcomes (3)

• Beck Depression Inventory (BDI; minimum: 0, maximum: 63; higher scores indicate higher depression)

  1 week and 6 weeks

• Medical Outcomes Study 36-item short-form health survey (MOS-SF; minimum: 0, maximum: 100, higher scores indicate better health status)

  1 week and 6 weeks

• Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression)

  6 weeks

Study Arms (2)

Active whole-body hyperthermia

ACTIVE COMPARATOR

Device: Active whole-body hyperthermia

Sham whole-body hyperthermia

SHAM COMPARATOR

Device: Sham whole-body hyperthermia

Interventions

Active whole-body hyperthermia DEVICE

Active water-filtered infrared whole-body hyperthermia as described in Janssen et al. (2016)

Active whole-body hyperthermia

Sham whole-body hyperthermia DEVICE

Sham water-filtered infrared whole-body hyperthermia as described in Janssen et al. (2016)

Sham whole-body hyperthermia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mental capacity to make decisions
• informed consent signed by the subject
• fluent in the German language
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University of Zurich, Institute of Psychology

Zurich, 8050, Switzerland

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Susanne Fischer, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Fischer, PhD

CONTACT

+41446357460; s.fischer@psychologie.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 21, 2024
• Study Start: June 15, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

CH (1)