HYPE1: Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

• Sponsor: Universität Duisburg-Essen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03906175
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 47.7
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 11, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Depression Severity: clinician-rated [week 6]

   Hamilton Rating Scale for Depression (HAMD-17)

Secondary Outcome Measures

1. Depression Severity: clinician-rated [week 1]

   Hamilton Rating Scale for Depression (HAMD-17)

2. Depression Severity: clinician-rated [week 3]

   Hamilton Rating Scale for Depression (HAMD-17)

3. Depression Severity: clinician-rated [week 12]

   Hamilton Rating Scale for Depression (HAMD-17)

4. Depression Severity: patient-rated [week 1]

   Beck Depression Inventory II (BDI-II)

5. Depression Severity: patient-rated [week 3]

   Beck Depression Inventory II (BDI-II)

6. Depression Severity: patient-rated [week 6]

   Beck Depression Inventory II (BDI-II)

7. Depression Severity: patient-rated [week 12]

   Beck Depression Inventory II (BDI-II)

8. Global improvement: clinician-rated [week 1]

   Clinical Global Impression Scale (CGI)

9. Global improvement: clinician-rated [week 3]

   Clinical Global Impression Scale (CGI)

10. Global improvement: clinician-rated [week 6]

    Clinical Global Impression Scale (CGI)

11. Global Improvement: clinician-rated [week 12]

    Clinical Global Impression Scale (CGI)

12. Global Functioning: clinician-rated [week 1]

    Global Assessment of Functioning Scale (GAF)

13. Global Functioning: clinician-rated [week 3]

    Global Assessment of Functioning Scale (GAF)

14. Global Functioning: clinician-rated [week 6]

    Global Assessment of Functioning Scale (GAF)

15. Global Functioning: clinician-rated [week 12]

    Global Assessment of Functioning Scale (GAF)

16. Fatigue: patient-rated [week 1]

    Multidimensional Fatigue Inventory (MFI)

17. Fatigue: patient-rated [week 3]

    Multidimensional Fatigue Inventory (MFI)

18. Fatigue: patient-rated [week 6]

    Multidimensional Fatigue Inventory (MFI)

19. Fatigue: patient-rated [week 12]

    Multidimensional Fatigue Inventory (MFI)

20. Stress: patient-rated [week 1]

    Perceived Stress-Scale (PSS)

21. Stress: patient-rated [week 3]

    Perceived Stress-Scale (PSS)

22. Stress: patient-rated [week 6]

    Perceived Stress-Scale (PSS)

23. Stress: patient-rated [week 12]

    Perceived Stress-Scale (PSS)

24. Quality of Life: patient-rated [week 1]

    Short Form Health Survey (SF-12)

25. Quality of Life: patient-rated [week 3]

    Short Form Health Survey (SF-12)

26. Quality of Life: patient-rated [week 6]

    Short Form Health Survey (SF-12)

27. Quality of Life: patient-rated [week 12]

    Short Form Health Survey (SF-12)

28. Biomarkers: interleukin 2 [week 1]

    IL-2

29. Biomarkers: interleukin 2 [week 3]

    IL-2

30. Biomarkers: interleukin 2 [week 6]

    IL-2

31. Biomarkers: interleukin 2 [week 12]

    IL-2

32. Biomarkers: interleukin 6 [week 1]

    IL-6

33. Biomarkers: interleukin 6 [week 3]

    IL-6

34. Biomarkers: interleukin 6 [week 6]

    IL-6

35. Biomarkers: interleukin 6 [week 12]

    IL-6

36. Biomarkers: interleukin 10 [week 1]

    IL-10

37. Biomarkers: interleukin 10 [week 3]

    IL-10

38. Biomarkers: interleukin 10 [week 6]

    IL-10

39. Biomarkers: interleukin 10 [week 12]

    IL-10

40. Biomarkers: tumor necrosis factor alpha [week 1]

    TNF-alpha

41. Biomarkers: tumor necrosis factor alpha [week 3]

    TNF-alpha

42. Biomarkers: tumor necrosis factor alpha [week 6]

    TNF-alpha

43. Biomarkers: tumor necrosis factor alpha [week 12]

    TNF-alpha

44. Biomarkers: high-sensitivity C-reactive protein [week 1]

    hs-CRP

45. Biomarkers: high-sensitivity C-reactive protein [week 3]

    hs-CRP

46. Biomarkers: high-sensitivity C-reactive protein [week 6]

    hs-CRP

47. Biomarkers: high-sensitivity C-reactive protein [week 12]

    hs-CRP

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

    sICAM-1

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

    sICAM-1

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

    sICAM-1

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

    sICAM-1

52. Biomarkers: tryptophan [week 1]

    tryptophan

53. Biomarkers: tryptophan [week 3]

    tryptophan

54. Biomarkers: tryptophan [week 6]

    tryptophan

55. Biomarkers: tryptophan [week 12]

    tryptophan

56. Biomarkers: kynurenine [week 1]

    kynurenine

57. Biomarkers: kynurenine [week 3]

    kynurenine

58. Biomarkers: kynurenine [week 6]

    kynurenine

59. Biomarkers: kynurenine [week 12]

    kynurenine

60. Biomarkers: neopterin [week 1]

    neopterin

61. Biomarkers: neopterin [week 3]

    neopterin

62. Biomarkers: neopterin [week 6]

    neopterin

63. Biomarkers: neopterin [week 12]

    neopterin

64. Adverse Events [week 1]

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

65. Adverse Events [week 3]

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

66. Adverse Events [week 6]

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

67. Adverse Events [week 12]

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

Other Outcome Measures

1. Treatment Expectations [week -1]

   Treatment Credibility Scale (TCS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, Psychotherapy and Addiciton Medicine, Kliniken Essen-Mitte	Essen		Germany	45276

Sponsors and Collaborators

• Universität Duisburg-Essen

Investigators

• Study Director: Gustav Dobos, Prof. MD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Holger Cramer, Research Director, Universität Duisburg-Essen
• ClinicalTrials.gov Identifier: NCT03906175
• Other Study ID Numbers: 18-8439-BO
• First Posted: Apr 8, 2019
• Last Update Posted: Nov 15, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Holger Cramer, Research Director, Universität Duisburg-Essen: Depression; Hyperthermia; Randomized Controlled Trial
• Additional relevant MeSH terms: Hyperthermia; Fever; Depression; Depressive Disorder

Study Results

No Results Posted as of Nov 15, 2021