Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

Overview

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.

Full Title of Study: “Whole-body Hyperthermia for Mild to Moderate Depressive Disorder – a Randomized Controlled Tiral”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2023

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Depression Severity: clinician-rated
    • Time Frame: week 6
    • Hamilton Rating Scale for Depression (HAMD-17)

Secondary Measures

  • Depression Severity: clinician-rated
    • Time Frame: week 1
    • Hamilton Rating Scale for Depression (HAMD-17)
  • Depression Severity: clinician-rated
    • Time Frame: week 3
    • Hamilton Rating Scale for Depression (HAMD-17)
  • Depression Severity: clinician-rated
    • Time Frame: week 12
    • Hamilton Rating Scale for Depression (HAMD-17)
  • Depression Severity: patient-rated
    • Time Frame: week 1
    • Beck Depression Inventory II (BDI-II)
  • Depression Severity: patient-rated
    • Time Frame: week 3
    • Beck Depression Inventory II (BDI-II)
  • Depression Severity: patient-rated
    • Time Frame: week 6
    • Beck Depression Inventory II (BDI-II)
  • Depression Severity: patient-rated
    • Time Frame: week 12
    • Beck Depression Inventory II (BDI-II)
  • Global improvement: clinician-rated
    • Time Frame: week 1
    • Clinical Global Impression Scale (CGI)
  • Global improvement: clinician-rated
    • Time Frame: week 3
    • Clinical Global Impression Scale (CGI)
  • Global improvement: clinician-rated
    • Time Frame: week 6
    • Clinical Global Impression Scale (CGI)
  • Global Improvement: clinician-rated
    • Time Frame: week 12
    • Clinical Global Impression Scale (CGI)
  • Global Functioning: clinician-rated
    • Time Frame: week 1
    • Global Assessment of Functioning Scale (GAF)
  • Global Functioning: clinician-rated
    • Time Frame: week 3
    • Global Assessment of Functioning Scale (GAF)
  • Global Functioning: clinician-rated
    • Time Frame: week 6
    • Global Assessment of Functioning Scale (GAF)
  • Global Functioning: clinician-rated
    • Time Frame: week 12
    • Global Assessment of Functioning Scale (GAF)
  • Fatigue: patient-rated
    • Time Frame: week 1
    • Multidimensional Fatigue Inventory (MFI)
  • Fatigue: patient-rated
    • Time Frame: week 3
    • Multidimensional Fatigue Inventory (MFI)
  • Fatigue: patient-rated
    • Time Frame: week 6
    • Multidimensional Fatigue Inventory (MFI)
  • Fatigue: patient-rated
    • Time Frame: week 12
    • Multidimensional Fatigue Inventory (MFI)
  • Stress: patient-rated
    • Time Frame: week 1
    • Perceived Stress-Scale (PSS)
  • Stress: patient-rated
    • Time Frame: week 3
    • Perceived Stress-Scale (PSS)
  • Stress: patient-rated
    • Time Frame: week 6
    • Perceived Stress-Scale (PSS)
  • Stress: patient-rated
    • Time Frame: week 12
    • Perceived Stress-Scale (PSS)
  • Quality of Life: patient-rated
    • Time Frame: week 1
    • Short Form Health Survey (SF-12)
  • Quality of Life: patient-rated
    • Time Frame: week 3
    • Short Form Health Survey (SF-12)
  • Quality of Life: patient-rated
    • Time Frame: week 6
    • Short Form Health Survey (SF-12)
  • Quality of Life: patient-rated
    • Time Frame: week 12
    • Short Form Health Survey (SF-12)
  • Biomarkers: interleukin 2
    • Time Frame: week 1
    • IL-2
  • Biomarkers: interleukin 2
    • Time Frame: week 3
    • IL-2
  • Biomarkers: interleukin 2
    • Time Frame: week 6
    • IL-2
  • Biomarkers: interleukin 2
    • Time Frame: week 12
    • IL-2
  • Biomarkers: interleukin 6
    • Time Frame: week 1
    • IL-6
  • Biomarkers: interleukin 6
    • Time Frame: week 3
    • IL-6
  • Biomarkers: interleukin 6
    • Time Frame: week 6
    • IL-6
  • Biomarkers: interleukin 6
    • Time Frame: week 12
    • IL-6
  • Biomarkers: interleukin 10
    • Time Frame: week 1
    • IL-10
  • Biomarkers: interleukin 10
    • Time Frame: week 3
    • IL-10
  • Biomarkers: interleukin 10
    • Time Frame: week 6
    • IL-10
  • Biomarkers: interleukin 10
    • Time Frame: week 12
    • IL-10
  • Biomarkers: tumor necrosis factor alpha
    • Time Frame: week 1
    • TNF-alpha
  • Biomarkers: tumor necrosis factor alpha
    • Time Frame: week 3
    • TNF-alpha
  • Biomarkers: tumor necrosis factor alpha
    • Time Frame: week 6
    • TNF-alpha
  • Biomarkers: tumor necrosis factor alpha
    • Time Frame: week 12
    • TNF-alpha
  • Biomarkers: high-sensitivity C-reactive protein
    • Time Frame: week 1
    • hs-CRP
  • Biomarkers: high-sensitivity C-reactive protein
    • Time Frame: week 3
    • hs-CRP
  • Biomarkers: high-sensitivity C-reactive protein
    • Time Frame: week 6
    • hs-CRP
  • Biomarkers: high-sensitivity C-reactive protein
    • Time Frame: week 12
    • hs-CRP
  • Biomarkers: soluble intercellular adhesion molecule-1
    • Time Frame: week 1
    • sICAM-1
  • Biomarkers: soluble intercellular adhesion molecule-1
    • Time Frame: week 3
    • sICAM-1
  • Biomarkers: soluble intercellular adhesion molecule-1
    • Time Frame: week 6
    • sICAM-1
  • Biomarkers: soluble intercellular adhesion molecule-1
    • Time Frame: week 12
    • sICAM-1
  • Biomarkers: tryptophan
    • Time Frame: week 1
    • tryptophan
  • Biomarkers: tryptophan
    • Time Frame: week 3
    • tryptophan
  • Biomarkers: tryptophan
    • Time Frame: week 6
    • tryptophan
  • Biomarkers: tryptophan
    • Time Frame: week 12
    • tryptophan
  • Biomarkers: kynurenine
    • Time Frame: week 1
    • kynurenine
  • Biomarkers: kynurenine
    • Time Frame: week 3
    • kynurenine
  • Biomarkers: kynurenine
    • Time Frame: week 6
    • kynurenine
  • Biomarkers: kynurenine
    • Time Frame: week 12
    • kynurenine
  • Biomarkers: neopterin
    • Time Frame: week 1
    • neopterin
  • Biomarkers: neopterin
    • Time Frame: week 3
    • neopterin
  • Biomarkers: neopterin
    • Time Frame: week 6
    • neopterin
  • Biomarkers: neopterin
    • Time Frame: week 12
    • neopterin
  • Adverse Events
    • Time Frame: week 1
    • Number of patients with adverse events, total number and type of adverse events
  • Adverse Events
    • Time Frame: week 3
    • Number of patients with adverse events, total number and type of adverse events
  • Adverse Events
    • Time Frame: week 6
    • Number of patients with adverse events, total number and type of adverse events
  • Adverse Events
    • Time Frame: week 12
    • Number of patients with adverse events, total number and type of adverse events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universität Duisburg-Essen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Holger Cramer, Research Director – Universität Duisburg-Essen
  • Overall Official(s)
    • Gustav Dobos, Prof. MD, Study Director, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

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