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Trial record 1 of 2 for:    Depression | Hyperthermia | Essen, Germany
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Whole-body Hyperthermia for Moderate to Severe Depressive Disorder (HYPE2)

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ClinicalTrials.gov Identifier: NCT03906149
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : November 5, 2020
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 addition to standard medical care in comparison to standard medical care alone on depressive symptom severity in patients with moderate to severe depressive disorder.

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


Condition or disease Intervention/treatment Phase
Depression, Unipolar Combination Product: Whole-body hyperthermia + standard medical care Combination Product: Standard medical care 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 Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

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 + standard medical care
Whole-body hyperthermia will be applied 2 times during 4 weeks in addition to guideline-based standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). 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.
 Combination Product: Whole-body hyperthermia + standard medical care
Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization) in addition to standard medical care. The hyperthermia will be applied using Heckel-HT3000 MPIIb. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.
Active Comparator: Standard medical care
Participants will maintain standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after randomization.
 Combination Product: Standard medical care
Standard medical care included guideline-based anti-depressive drug treatment in combination with psychotherapy. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.


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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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)
  • Moderate depression: 17-23 points on the HAMD-17 or severe depression: ≥24 points on the HAMD-17

Exclusion Criteria:

  • 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): NCT03906149


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: NCT03906149    
Other Study ID Numbers: 18-8440-BO
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
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