Major Depressive DisorderNCT06323785
Whole-body Hyperthermia for Depression
A study testing Active whole-body hyperthermia in people with Major Depressive Disorder, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Active whole-body hyperthermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jun 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich, Institute of Psychology
Zurich, 8050
Susanne Fischer, PhD, +41446357460, s.fischer@psychologie.uzh.ch
About this study
Official title: Randomised Sham-controlled Trial of Whole-body Hyperthermia for Depression
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
- Being tested
- Active whole-body hyperthermia, Sham whole-body hyperthermia
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active whole-body hyperthermiaDevice
Active water-filtered infrared whole-body hyperthermia as described in Janssen et al. (2016)
Sham whole-body hyperthermiaDevice
Sham water-filtered infrared whole-body hyperthermia as described in Janssen et al. (2016)
| Study group | Role | What they receive |
|---|---|---|
| Active whole-body hyperthermia | Active comparator | Not described Receives: Device: Active whole-body hyperthermia |
| Sham whole-body hyperthermia | Sham comparator | Not described Receives: Device: Sham whole-body hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression)
Depressive symptoms (observer-rated)
Measured: 1 week
Secondary outcomes (3)
Beck Depression Inventory (BDI; minimum: 0, maximum: 63; higher scores indicate higher depression)
Depressive symptoms (self-reported)
Measured: 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)
Quality of life
Measured: 1 week and 6 weeks
Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression)
Depressive symptoms (observer-rated)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start15 Jun 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Fischer, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323785
- Sponsor's protocol ID
- 2022-D0067
- Status last verified
- Jun 2024
- First submitted
- 28 Feb 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Sham-controlled Trial of Whole-body Hyperthermia for Depression
- ClinicalTrials.gov ID
- NCT06323785
- Acronym / sponsor ID
- 2022-D0067
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active whole-body hyperthermia | Active comparator | Device: Active whole-body hyperthermia |
| Sham whole-body hyperthermia | Sham comparator | Device: Sham whole-body hyperthermia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active whole-body hyperthermiaActive water-filtered infrared whole-body hyperthermia as described in Janssen et al. (2016) | Device | Active whole-body hyperthermia |
| Sham whole-body hyperthermiaSham water-filtered infrared whole-body hyperthermia as described in Janssen et al. (2016) | Device | Sham whole-body hyperthermia |
Primary outcome
Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression)
Time frame: 1 week
Depressive symptoms (observer-rated)
3 secondary outcomes
Beck Depression Inventory (BDI; minimum: 0, maximum: 63; higher scores indicate higher depression)
Time frame: 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)
Time frame: 1 week and 6 weeks
Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Fischer, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active whole-body hyperthermia in people with Major Depressive Disorder, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Fischer, PhD (+41446357460, s.fischer@psychologie.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.