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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 : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen

Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 8, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
Depression Severity: clinician-rated [ Time Frame: week 6 ]
Hamilton Rating Scale for Depression (HAMD-17)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 24, 2019)
Treatment Expectations [ Time Frame: week -1 ]
Treatment Credibility Scale (TCS)
Original Other Pre-specified Outcome Measures
 (submitted: April 5, 2019)
  • Sweat Production [ Time Frame: week 0 ]
    Gravimetry
  • Sweat Production [ Time Frame: week 2 ]
    Gravimetry
  • Treatment Expectations [ Time Frame: week -1 ]
    Treatment Credibility Scale (TCS)
 
Descriptive Information
Brief Title  ICMJE Whole-body Hyperthermia for Moderate to Severe Depressive Disorder
Official Title  ICMJE Whole-body Hyperthermia for Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression, Unipolar
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Combination Product: Whole-body hyperthermia + standard medical care
  • 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.
    Intervention: Combination Product: Standard medical care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2019)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Holger Cramer, PhD +4920117425015 h.cramer@kem-med.com
Contact: Heidemarie Haller, PhD +4920117425044 h.haller@kem-med.com
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03906149
Other Study ID Numbers  ICMJE 18-8440-BO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Holger Cramer, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gustav Dobos, Prof. MD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Germany
PRS Account Universität Duisburg-Essen
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP