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Trial record 2 of 2 for:    Depression | Hyperthermia | Essen, Germany
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Whole-body Hyperthermia for Mild to Moderate Depressive Disorder (HYPE1)

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ClinicalTrials.gov Identifier: NCT03906175
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen

Study Description
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Brief 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.

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


Condition or disease Intervention/treatment Phase
Depression, Unipolar Device: Whole-body hyperthermia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Whole-body Hyperthermia for Mild to Moderate Depressive Disorder - a Randomized Controlled Tiral
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: Whole-body hyperthermia
Whole-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.
 Device: Whole-body hyperthermia
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.
No Intervention: Wait list
Participants 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.


Outcome Measures
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Primary Outcome Measures :
  1. Depression Severity: clinician-rated [ Time Frame: week 6 ]
    Hamilton Rating Scale for Depression (HAMD-17)


Secondary Outcome Measures :
  1. Depression Severity: clinician-rated [ Time Frame: week 1 ]
    Hamilton Rating Scale for Depression (HAMD-17)

  2. Depression Severity: clinician-rated [ Time Frame: week 3 ]
    Hamilton Rating Scale for Depression (HAMD-17)

  3. Depression Severity: clinician-rated [ Time Frame: week 12 ]
    Hamilton Rating Scale for Depression (HAMD-17)

  4. Depression Severity: patient-rated [ Time Frame: week 1 ]
    Beck Depression Inventory II (BDI-II)

  5. Depression Severity: patient-rated [ Time Frame: week 3 ]
    Beck Depression Inventory II (BDI-II)

  6. Depression Severity: patient-rated [ Time Frame: week 6 ]
    Beck Depression Inventory II (BDI-II)

  7. Depression Severity: patient-rated [ Time Frame: week 12 ]
    Beck Depression Inventory II (BDI-II)

  8. Global improvement: clinician-rated [ Time Frame: week 1 ]
    Clinical Global Impression Scale (CGI)

  9. Global improvement: clinician-rated [ Time Frame: week 3 ]
    Clinical Global Impression Scale (CGI)

  10. Global improvement: clinician-rated [ Time Frame: week 6 ]
    Clinical Global Impression Scale (CGI)

  11. Global Improvement: clinician-rated [ Time Frame: week 12 ]
    Clinical Global Impression Scale (CGI)

  12. Global Functioning: clinician-rated [ Time Frame: week 1 ]
    Global Assessment of Functioning Scale (GAF)

  13. Global Functioning: clinician-rated [ Time Frame: week 3 ]
    Global Assessment of Functioning Scale (GAF)

  14. Global Functioning: clinician-rated [ Time Frame: week 6 ]
    Global Assessment of Functioning Scale (GAF)

  15. Global Functioning: clinician-rated [ Time Frame: week 12 ]
    Global Assessment of Functioning Scale (GAF)

  16. Fatigue: patient-rated [ Time Frame: week 1 ]
    Multidimensional Fatigue Inventory (MFI)

  17. Fatigue: patient-rated [ Time Frame: week 3 ]
    Multidimensional Fatigue Inventory (MFI)

  18. Fatigue: patient-rated [ Time Frame: week 6 ]
    Multidimensional Fatigue Inventory (MFI)

  19. Fatigue: patient-rated [ Time Frame: week 12 ]
    Multidimensional Fatigue Inventory (MFI)

  20. Stress: patient-rated [ Time Frame: week 1 ]
    Perceived Stress-Scale (PSS)

  21. Stress: patient-rated [ Time Frame: week 3 ]
    Perceived Stress-Scale (PSS)

  22. Stress: patient-rated [ Time Frame: week 6 ]
    Perceived Stress-Scale (PSS)

  23. Stress: patient-rated [ Time Frame: week 12 ]
    Perceived Stress-Scale (PSS)

  24. Quality of Life: patient-rated [ Time Frame: week 1 ]
    Short Form Health Survey (SF-12)

  25. Quality of Life: patient-rated [ Time Frame: week 3 ]
    Short Form Health Survey (SF-12)

  26. Quality of Life: patient-rated [ Time Frame: week 6 ]
    Short Form Health Survey (SF-12)

  27. Quality of Life: patient-rated [ Time Frame: week 12 ]
    Short Form Health Survey (SF-12)

  28. Biomarkers: interleukin 2 [ Time Frame: week 1 ]
    IL-2

  29. Biomarkers: interleukin 2 [ Time Frame: week 3 ]
    IL-2

  30. Biomarkers: interleukin 2 [ Time Frame: week 6 ]
    IL-2

  31. Biomarkers: interleukin 2 [ Time Frame: week 12 ]
    IL-2

  32. Biomarkers: interleukin 6 [ Time Frame: week 1 ]
    IL-6

  33. Biomarkers: interleukin 6 [ Time Frame: week 3 ]
    IL-6

  34. Biomarkers: interleukin 6 [ Time Frame: week 6 ]
    IL-6

  35. Biomarkers: interleukin 6 [ Time Frame: week 12 ]
    IL-6

  36. Biomarkers: interleukin 10 [ Time Frame: week 1 ]
    IL-10

  37. Biomarkers: interleukin 10 [ Time Frame: week 3 ]
    IL-10

  38. Biomarkers: interleukin 10 [ Time Frame: week 6 ]
    IL-10

  39. Biomarkers: interleukin 10 [ Time Frame: week 12 ]
    IL-10

  40. Biomarkers: tumor necrosis factor alpha [ Time Frame: week 1 ]
    TNF-alpha

  41. Biomarkers: tumor necrosis factor alpha [ Time Frame: week 3 ]
    TNF-alpha

  42. Biomarkers: tumor necrosis factor alpha [ Time Frame: week 6 ]
    TNF-alpha

  43. Biomarkers: tumor necrosis factor alpha [ Time Frame: week 12 ]
    TNF-alpha

  44. Biomarkers: high-sensitivity C-reactive protein [ Time Frame: week 1 ]
    hs-CRP

  45. Biomarkers: high-sensitivity C-reactive protein [ Time Frame: week 3 ]
    hs-CRP

  46. Biomarkers: high-sensitivity C-reactive protein [ Time Frame: week 6 ]
    hs-CRP

  47. Biomarkers: high-sensitivity C-reactive protein [ Time Frame: week 12 ]
    hs-CRP

  48. Biomarkers: soluble intercellular adhesion molecule-1 [ Time Frame: week 1 ]
    sICAM-1

  49. Biomarkers: soluble intercellular adhesion molecule-1 [ Time Frame: week 3 ]
    sICAM-1

  50. Biomarkers: soluble intercellular adhesion molecule-1 [ Time Frame: week 6 ]
    sICAM-1

  51. Biomarkers: soluble intercellular adhesion molecule-1 [ Time Frame: week 12 ]
    sICAM-1

  52. Biomarkers: tryptophan [ Time Frame: week 1 ]
    tryptophan

  53. Biomarkers: tryptophan [ Time Frame: week 3 ]
    tryptophan

  54. Biomarkers: tryptophan [ Time Frame: week 6 ]
    tryptophan

  55. Biomarkers: tryptophan [ Time Frame: week 12 ]
    tryptophan

  56. Biomarkers: kynurenine [ Time Frame: week 1 ]
    kynurenine

  57. Biomarkers: kynurenine [ Time Frame: week 3 ]
    kynurenine

  58. Biomarkers: kynurenine [ Time Frame: week 6 ]
    kynurenine

  59. Biomarkers: kynurenine [ Time Frame: week 12 ]
    kynurenine

  60. Biomarkers: neopterin [ Time Frame: week 1 ]
    neopterin

  61. Biomarkers: neopterin [ Time Frame: week 3 ]
    neopterin

  62. Biomarkers: neopterin [ Time Frame: week 6 ]
    neopterin

  63. Biomarkers: neopterin [ Time Frame: week 12 ]
    neopterin

  64. Adverse Events [ Time Frame: week 1 ]
    Number of patients with adverse events, total number and type of adverse events

  65. Adverse Events [ Time Frame: week 3 ]
    Number of patients with adverse events, total number and type of adverse events

  66. Adverse Events [ Time Frame: week 6 ]
    Number of patients with adverse events, total number and type of adverse events

  67. Adverse Events [ Time Frame: week 12 ]
    Number of patients with adverse events, total number and type of adverse events


Other Outcome Measures:
  1. Treatment Expectations [ Time Frame: week -1 ]
    Treatment Credibility Scale (TCS)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906175


Contacts
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Contact: Holger Cramer, PhD +4920117425015 h.cramer@kem-med.com
Contact: Heidemarie Haller, PhD +4920117425044 h.haller@kem-med.com

Locations
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Germany
Department of Psychiatry, Psychotherapy and Addiciton Medicine, Kliniken Essen-Mitte Recruiting
Essen, Germany, 45276
Contact: Martin Schäfer, Prof. MD    +4920117430001    m.schaefer@kem-med.com   
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
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Study Director: Gustav Dobos, Prof. MD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Germany
More Information
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Responsible Party: Holger Cramer, Research Director, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT03906175    
Other Study ID Numbers: 18-8439-BO
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holger Cramer, Universität Duisburg-Essen:
Depression
Hyperthermia
Randomized Controlled Trial
Additional relevant MeSH terms:
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Fever
Depression
Depressive Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Body Temperature Changes
Signs and Symptoms