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Depression, UnipolarHYPE1NCT03906175

Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

A study testing Whole-body hyperthermia in people with Depression, Unipolar, run by Universität Duisburg-Essen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression, Unipolar
What is being tested?
Whole-body hyperthermia
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteGermany
Study dates
11 Jun 2019to 1 Sep 2023
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

  • Unipolar depression (diagnosed according to the DSM-IV)
  • Mild depression: 8-16 points on the HAMD-17 or moderate depression: 17-23 points on the HAMD-17

Who cannot join

  • Current psychotherapy
  • Antidepressant drug treatment in the last 4 weeks before study inclusion
  • Participants who did not respond to prior antidepressant drug treatment, electroconvulsive therapy, or sleep deprivation (therapy-resistant depression)
  • Acute suicidality
  • Prior treatment with whole-body hyperthermia
  • Contraindications to hyperthermia treatment: acute or feverish infections, severe cardiovascular diseases (e.g. angina pectoris, heart failure, thrombosis, bleeding diathesis), severe gastrointestinal diseases (e.g. renal insufficiency, hepatitis, liver cirrhosis, peptic ulcer), severe neurological diseases (e.g. epilepsy, multiple sclerosis, cerebrovascular malformations or brain tumors), severe endocrine diseases (e.g. hyperthyroidism), or oncological diseases without remission
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  • Participants taking anti-inflammatory or immunosuppressive drugs
  • Participants with severe psychiatric comorbidities (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, dementia, ADHD, obsessive-compulsive disorder, PTSD, alcohol or drug addiction)
  • Women during pregnancy and breastfeeding
  • Lack of ability to consent

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte

    Essen, 45276

Other trials in Germany

About this study

Official title: Whole-body Hyperthermia for Mild to Moderate Depressive Disorder - a Randomized Controlled Tiral

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment.

Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.

Being tested
Whole-body hyperthermia
Keywords
Depression, Hyperthermia, Randomized Controlled Trial
Medical subject headings
Depressive Disorder, Depression, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole-body hyperthermiaDevice

    Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization). The hyperthermia will be applied using Heckel-HT3000 MPIIb.

Study groups in NCT03906175
Study groupRoleWhat they receive
Whole-body hyperthermiaExperimentalWhole-body hyperthermia will be applied 2 times during 4 weeks. At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia.
Receives: Device: Whole-body hyperthermia
Wait listNo interventionParticipants will wait for 6 weeks (primary outcome assessment point). They will then receive the same treatment procedure as the experimental group. They will also be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression Severity: clinician-rated

    Hamilton Rating Scale for Depression (HAMD-17)

    Measured: week 6

Secondary outcomes (67)

  1. Depression Severity: clinician-rated

    Hamilton Rating Scale for Depression (HAMD-17)

    Measured: week 1

  2. Depression Severity: clinician-rated

    Hamilton Rating Scale for Depression (HAMD-17)

    Measured: week 3

  3. Depression Severity: clinician-rated

    Hamilton Rating Scale for Depression (HAMD-17)

    Measured: week 12

  4. Depression Severity: patient-rated

    Beck Depression Inventory II (BDI-II)

    Measured: week 1

  5. Depression Severity: patient-rated

    Beck Depression Inventory II (BDI-II)

    Measured: week 3

  6. Depression Severity: patient-rated

    Beck Depression Inventory II (BDI-II)

    Measured: week 6

  7. Depression Severity: patient-rated

    Beck Depression Inventory II (BDI-II)

    Measured: week 12

  8. Global improvement: clinician-rated

    Clinical Global Impression Scale (CGI)

    Measured: week 1

  9. Global improvement: clinician-rated

    Clinical Global Impression Scale (CGI)

    Measured: week 3

  10. Global improvement: clinician-rated

    Clinical Global Impression Scale (CGI)

    Measured: week 6

  11. Global Improvement: clinician-rated

    Clinical Global Impression Scale (CGI)

    Measured: week 12

  12. Global Functioning: clinician-rated

    Global Assessment of Functioning Scale (GAF)

    Measured: week 1

  13. Global Functioning: clinician-rated

    Global Assessment of Functioning Scale (GAF)

    Measured: week 3

  14. Global Functioning: clinician-rated

    Global Assessment of Functioning Scale (GAF)

    Measured: week 6

  15. Global Functioning: clinician-rated

    Global Assessment of Functioning Scale (GAF)

    Measured: week 12

  16. Fatigue: patient-rated

    Multidimensional Fatigue Inventory (MFI)

    Measured: week 1

  17. Fatigue: patient-rated

    Multidimensional Fatigue Inventory (MFI)

    Measured: week 3

  18. Fatigue: patient-rated

    Multidimensional Fatigue Inventory (MFI)

    Measured: week 6

  19. Fatigue: patient-rated

    Multidimensional Fatigue Inventory (MFI)

    Measured: week 12

  20. Stress: patient-rated

    Perceived Stress-Scale (PSS)

    Measured: week 1

  21. Stress: patient-rated

    Perceived Stress-Scale (PSS)

    Measured: week 3

  22. Stress: patient-rated

    Perceived Stress-Scale (PSS)

    Measured: week 6

  23. Stress: patient-rated

    Perceived Stress-Scale (PSS)

    Measured: week 12

  24. Quality of Life: patient-rated

    Short Form Health Survey (SF-12)

    Measured: week 1

  25. Quality of Life: patient-rated

    Short Form Health Survey (SF-12)

    Measured: week 3

  26. Quality of Life: patient-rated

    Short Form Health Survey (SF-12)

    Measured: week 6

  27. Quality of Life: patient-rated

    Short Form Health Survey (SF-12)

    Measured: week 12

  28. Biomarkers: interleukin 2

    IL-2

    Measured: week 1

  29. Biomarkers: interleukin 2

    IL-2

    Measured: week 3

  30. Biomarkers: interleukin 2

    IL-2

    Measured: week 6

  31. Biomarkers: interleukin 2

    IL-2

    Measured: week 12

  32. Biomarkers: interleukin 6

    IL-6

    Measured: week 1

  33. Biomarkers: interleukin 6

    IL-6

    Measured: week 3

  34. Biomarkers: interleukin 6

    IL-6

    Measured: week 6

  35. Biomarkers: interleukin 6

    IL-6

    Measured: week 12

  36. Biomarkers: interleukin 10

    IL-10

    Measured: week 1

  37. Biomarkers: interleukin 10

    IL-10

    Measured: week 3

  38. Biomarkers: interleukin 10

    IL-10

    Measured: week 6

  39. Biomarkers: interleukin 10

    IL-10

    Measured: week 12

  40. Biomarkers: tumor necrosis factor alpha

    TNF-alpha

    Measured: week 1

  41. Biomarkers: tumor necrosis factor alpha

    TNF-alpha

    Measured: week 3

  42. Biomarkers: tumor necrosis factor alpha

    TNF-alpha

    Measured: week 6

  43. Biomarkers: tumor necrosis factor alpha

    TNF-alpha

    Measured: week 12

  44. Biomarkers: high-sensitivity C-reactive protein

    hs-CRP

    Measured: week 1

  45. Biomarkers: high-sensitivity C-reactive protein

    hs-CRP

    Measured: week 3

  46. Biomarkers: high-sensitivity C-reactive protein

    hs-CRP

    Measured: week 6

  47. Biomarkers: high-sensitivity C-reactive protein

    hs-CRP

    Measured: week 12

  48. Biomarkers: soluble intercellular adhesion molecule-1

    sICAM-1

    Measured: week 1

  49. Biomarkers: soluble intercellular adhesion molecule-1

    sICAM-1

    Measured: week 3

  50. Biomarkers: soluble intercellular adhesion molecule-1

    sICAM-1

    Measured: week 6

  51. Biomarkers: soluble intercellular adhesion molecule-1

    sICAM-1

    Measured: week 12

  52. Biomarkers: tryptophan

    tryptophan

    Measured: week 1

  53. Biomarkers: tryptophan

    tryptophan

    Measured: week 3

  54. Biomarkers: tryptophan

    tryptophan

    Measured: week 6

  55. Biomarkers: tryptophan

    tryptophan

    Measured: week 12

  56. Biomarkers: kynurenine

    kynurenine

    Measured: week 1

  57. Biomarkers: kynurenine

    kynurenine

    Measured: week 3

  58. Biomarkers: kynurenine

    kynurenine

    Measured: week 6

  59. Biomarkers: kynurenine

    kynurenine

    Measured: week 12

  60. Biomarkers: neopterin

    neopterin

    Measured: week 1

  61. Biomarkers: neopterin

    neopterin

    Measured: week 3

  62. Biomarkers: neopterin

    neopterin

    Measured: week 6

  63. Biomarkers: neopterin

    neopterin

    Measured: week 12

  64. Adverse Events

    Number of patients with adverse events, total number and type of adverse events

    Measured: week 1

  65. Adverse Events

    Number of patients with adverse events, total number and type of adverse events

    Measured: week 3

  66. Adverse Events

    Number of patients with adverse events, total number and type of adverse events

    Measured: week 6

  67. Adverse Events

    Number of patients with adverse events, total number and type of adverse events

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2019
  2. Study start11 Jun 2019
  3. Primary completion31 Aug 2023
  4. Study completion1 Sep 2023

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03906175
Sponsor's protocol ID
18-8439-BO
Acronym
HYPE1
Status last verified
Dec 2023
First submitted
4 Apr 2019
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Whole-body hyperthermia in people with Depression, Unipolar, run by Universität Duisburg-Essen at 1 site in Germany.

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 2 inclusion and 10 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: finished, as of the sponsor's last update on 4 Dec 2023. 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 Germany. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Severity: clinician-rated (time frame: week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03906175.

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 4 Dec 2023.

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