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Completed

NCT Number: NCT03906149

Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

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.

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Key information

Conditions

Depression, Unipolar Behavior Behavioral Symptoms Body Temperature Changes Depression Depressive Disorder Heat Stress Disorders Hyperthermia Mental Disorders Mood Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Essen, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole-body hyperthermia + standard medical care

Combination Product

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.

Standard medical care

Combination Product

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.

Primary outcomes

  1. Depression Severity: clinician-rated

    Time frame: week 6

    Hamilton Rating Scale for Depression (HAMD-17)

Secondary outcomes

  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 outcomes

  1. Treatment Expectations

    Time frame: week -1

    Treatment Credibility Scale (TCS)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Whole-body Hyperthermia for Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral

Acronym: HYPE2

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2019
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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