Back to resultsWhole-body Hyperthermia for Mild to Moderate Depressive Disorder (HYPE1)
Primary Purpose
Depression, Unipolar
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Whole-body hyperthermia
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Unipolar focused on measuring Depression, Hyperthermia, Randomized Controlled Trial
Eligibility Criteria
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
Sites / Locations
- Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-MitteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Whole-body hyperthermia
Wait list
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Depression Severity: clinician-rated
Hamilton Rating Scale for Depression (HAMD-17)
Secondary Outcome Measures
Depression Severity: clinician-rated
Hamilton Rating Scale for Depression (HAMD-17)
Depression Severity: clinician-rated
Hamilton Rating Scale for Depression (HAMD-17)
Depression Severity: clinician-rated
Hamilton Rating Scale for Depression (HAMD-17)
Depression Severity: patient-rated
Beck Depression Inventory II (BDI-II)
Depression Severity: patient-rated
Beck Depression Inventory II (BDI-II)
Depression Severity: patient-rated
Beck Depression Inventory II (BDI-II)
Depression Severity: patient-rated
Beck Depression Inventory II (BDI-II)
Global improvement: clinician-rated
Clinical Global Impression Scale (CGI)
Global improvement: clinician-rated
Clinical Global Impression Scale (CGI)
Global improvement: clinician-rated
Clinical Global Impression Scale (CGI)
Global Improvement: clinician-rated
Clinical Global Impression Scale (CGI)
Global Functioning: clinician-rated
Global Assessment of Functioning Scale (GAF)
Global Functioning: clinician-rated
Global Assessment of Functioning Scale (GAF)
Global Functioning: clinician-rated
Global Assessment of Functioning Scale (GAF)
Global Functioning: clinician-rated
Global Assessment of Functioning Scale (GAF)
Fatigue: patient-rated
Multidimensional Fatigue Inventory (MFI)
Fatigue: patient-rated
Multidimensional Fatigue Inventory (MFI)
Fatigue: patient-rated
Multidimensional Fatigue Inventory (MFI)
Fatigue: patient-rated
Multidimensional Fatigue Inventory (MFI)
Stress: patient-rated
Perceived Stress-Scale (PSS)
Stress: patient-rated
Perceived Stress-Scale (PSS)
Stress: patient-rated
Perceived Stress-Scale (PSS)
Stress: patient-rated
Perceived Stress-Scale (PSS)
Quality of Life: patient-rated
Short Form Health Survey (SF-12)
Quality of Life: patient-rated
Short Form Health Survey (SF-12)
Quality of Life: patient-rated
Short Form Health Survey (SF-12)
Quality of Life: patient-rated
Short Form Health Survey (SF-12)
Biomarkers: interleukin 2
IL-2
Biomarkers: interleukin 2
IL-2
Biomarkers: interleukin 2
IL-2
Biomarkers: interleukin 2
IL-2
Biomarkers: interleukin 6
IL-6
Biomarkers: interleukin 6
IL-6
Biomarkers: interleukin 6
IL-6
Biomarkers: interleukin 6
IL-6
Biomarkers: interleukin 10
IL-10
Biomarkers: interleukin 10
IL-10
Biomarkers: interleukin 10
IL-10
Biomarkers: interleukin 10
IL-10
Biomarkers: tumor necrosis factor alpha
TNF-alpha
Biomarkers: tumor necrosis factor alpha
TNF-alpha
Biomarkers: tumor necrosis factor alpha
TNF-alpha
Biomarkers: tumor necrosis factor alpha
TNF-alpha
Biomarkers: high-sensitivity C-reactive protein
hs-CRP
Biomarkers: high-sensitivity C-reactive protein
hs-CRP
Biomarkers: high-sensitivity C-reactive protein
hs-CRP
Biomarkers: high-sensitivity C-reactive protein
hs-CRP
Biomarkers: soluble intercellular adhesion molecule-1
sICAM-1
Biomarkers: soluble intercellular adhesion molecule-1
sICAM-1
Biomarkers: soluble intercellular adhesion molecule-1
sICAM-1
Biomarkers: soluble intercellular adhesion molecule-1
sICAM-1
Biomarkers: tryptophan
tryptophan
Biomarkers: tryptophan
tryptophan
Biomarkers: tryptophan
tryptophan
Biomarkers: tryptophan
tryptophan
Biomarkers: kynurenine
kynurenine
Biomarkers: kynurenine
kynurenine
Biomarkers: kynurenine
kynurenine
Biomarkers: kynurenine
kynurenine
Biomarkers: neopterin
neopterin
Biomarkers: neopterin
neopterin
Biomarkers: neopterin
neopterin
Biomarkers: neopterin
neopterin
Adverse Events
Number of patients with adverse events, total number and type of adverse events
Adverse Events
Number of patients with adverse events, total number and type of adverse events
Adverse Events
Number of patients with adverse events, total number and type of adverse events
Adverse Events
Number of patients with adverse events, total number and type of adverse events
Full Information
NCT ID
NCT03906175
First Posted
April 4, 2019
Last Updated
December 2, 2022
Sponsor
Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT03906175
Brief Title
Whole-body Hyperthermia for Mild to Moderate Depressive Disorder
Acronym
HYPE1
Official Title
Whole-body Hyperthermia for Mild to Moderate Depressive Disorder - a Randomized Controlled Tiral
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Unipolar
Keywords
Depression, Hyperthermia, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole-body hyperthermia
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Whole-body hyperthermia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression Severity: clinician-rated
Description
Hamilton Rating Scale for Depression (HAMD-17)
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Depression Severity: clinician-rated
Description
Hamilton Rating Scale for Depression (HAMD-17)
Time Frame
week 1
Title
Depression Severity: clinician-rated
Description
Hamilton Rating Scale for Depression (HAMD-17)
Time Frame
week 3
Title
Depression Severity: clinician-rated
Description
Hamilton Rating Scale for Depression (HAMD-17)
Time Frame
week 12
Title
Depression Severity: patient-rated
Description
Beck Depression Inventory II (BDI-II)
Time Frame
week 1
Title
Depression Severity: patient-rated
Description
Beck Depression Inventory II (BDI-II)
Time Frame
week 3
Title
Depression Severity: patient-rated
Description
Beck Depression Inventory II (BDI-II)
Time Frame
week 6
Title
Depression Severity: patient-rated
Description
Beck Depression Inventory II (BDI-II)
Time Frame
week 12
Title
Global improvement: clinician-rated
Description
Clinical Global Impression Scale (CGI)
Time Frame
week 1
Title
Global improvement: clinician-rated
Description
Clinical Global Impression Scale (CGI)
Time Frame
week 3
Title
Global improvement: clinician-rated
Description
Clinical Global Impression Scale (CGI)
Time Frame
week 6
Title
Global Improvement: clinician-rated
Description
Clinical Global Impression Scale (CGI)
Time Frame
week 12
Title
Global Functioning: clinician-rated
Description
Global Assessment of Functioning Scale (GAF)
Time Frame
week 1
Title
Global Functioning: clinician-rated
Description
Global Assessment of Functioning Scale (GAF)
Time Frame
week 3
Title
Global Functioning: clinician-rated
Description
Global Assessment of Functioning Scale (GAF)
Time Frame
week 6
Title
Global Functioning: clinician-rated
Description
Global Assessment of Functioning Scale (GAF)
Time Frame
week 12
Title
Fatigue: patient-rated
Description
Multidimensional Fatigue Inventory (MFI)
Time Frame
week 1
Title
Fatigue: patient-rated
Description
Multidimensional Fatigue Inventory (MFI)
Time Frame
week 3
Title
Fatigue: patient-rated
Description
Multidimensional Fatigue Inventory (MFI)
Time Frame
week 6
Title
Fatigue: patient-rated
Description
Multidimensional Fatigue Inventory (MFI)
Time Frame
week 12
Title
Stress: patient-rated
Description
Perceived Stress-Scale (PSS)
Time Frame
week 1
Title
Stress: patient-rated
Description
Perceived Stress-Scale (PSS)
Time Frame
week 3
Title
Stress: patient-rated
Description
Perceived Stress-Scale (PSS)
Time Frame
week 6
Title
Stress: patient-rated
Description
Perceived Stress-Scale (PSS)
Time Frame
week 12
Title
Quality of Life: patient-rated
Description
Short Form Health Survey (SF-12)
Time Frame
week 1
Title
Quality of Life: patient-rated
Description
Short Form Health Survey (SF-12)
Time Frame
week 3
Title
Quality of Life: patient-rated
Description
Short Form Health Survey (SF-12)
Time Frame
week 6
Title
Quality of Life: patient-rated
Description
Short Form Health Survey (SF-12)
Time Frame
week 12
Title
Biomarkers: interleukin 2
Description
IL-2
Time Frame
week 1
Title
Biomarkers: interleukin 2
Description
IL-2
Time Frame
week 3
Title
Biomarkers: interleukin 2
Description
IL-2
Time Frame
week 6
Title
Biomarkers: interleukin 2
Description
IL-2
Time Frame
week 12
Title
Biomarkers: interleukin 6
Description
IL-6
Time Frame
week 1
Title
Biomarkers: interleukin 6
Description
IL-6
Time Frame
week 3
Title
Biomarkers: interleukin 6
Description
IL-6
Time Frame
week 6
Title
Biomarkers: interleukin 6
Description
IL-6
Time Frame
week 12
Title
Biomarkers: interleukin 10
Description
IL-10
Time Frame
week 1
Title
Biomarkers: interleukin 10
Description
IL-10
Time Frame
week 3
Title
Biomarkers: interleukin 10
Description
IL-10
Time Frame
week 6
Title
Biomarkers: interleukin 10
Description
IL-10
Time Frame
week 12
Title
Biomarkers: tumor necrosis factor alpha
Description
TNF-alpha
Time Frame
week 1
Title
Biomarkers: tumor necrosis factor alpha
Description
TNF-alpha
Time Frame
week 3
Title
Biomarkers: tumor necrosis factor alpha
Description
TNF-alpha
Time Frame
week 6
Title
Biomarkers: tumor necrosis factor alpha
Description
TNF-alpha
Time Frame
week 12
Title
Biomarkers: high-sensitivity C-reactive protein
Description
hs-CRP
Time Frame
week 1
Title
Biomarkers: high-sensitivity C-reactive protein
Description
hs-CRP
Time Frame
week 3
Title
Biomarkers: high-sensitivity C-reactive protein
Description
hs-CRP
Time Frame
week 6
Title
Biomarkers: high-sensitivity C-reactive protein
Description
hs-CRP
Time Frame
week 12
Title
Biomarkers: soluble intercellular adhesion molecule-1
Description
sICAM-1
Time Frame
week 1
Title
Biomarkers: soluble intercellular adhesion molecule-1
Description
sICAM-1
Time Frame
week 3
Title
Biomarkers: soluble intercellular adhesion molecule-1
Description
sICAM-1
Time Frame
week 6
Title
Biomarkers: soluble intercellular adhesion molecule-1
Description
sICAM-1
Time Frame
week 12
Title
Biomarkers: tryptophan
Description
tryptophan
Time Frame
week 1
Title
Biomarkers: tryptophan
Description
tryptophan
Time Frame
week 3
Title
Biomarkers: tryptophan
Description
tryptophan
Time Frame
week 6
Title
Biomarkers: tryptophan
Description
tryptophan
Time Frame
week 12
Title
Biomarkers: kynurenine
Description
kynurenine
Time Frame
week 1
Title
Biomarkers: kynurenine
Description
kynurenine
Time Frame
week 3
Title
Biomarkers: kynurenine
Description
kynurenine
Time Frame
week 6
Title
Biomarkers: kynurenine
Description
kynurenine
Time Frame
week 12
Title
Biomarkers: neopterin
Description
neopterin
Time Frame
week 1
Title
Biomarkers: neopterin
Description
neopterin
Time Frame
week 3
Title
Biomarkers: neopterin
Description
neopterin
Time Frame
week 6
Title
Biomarkers: neopterin
Description
neopterin
Time Frame
week 12
Title
Adverse Events
Description
Number of patients with adverse events, total number and type of adverse events
Time Frame
week 1
Title
Adverse Events
Description
Number of patients with adverse events, total number and type of adverse events
Time Frame
week 3
Title
Adverse Events
Description
Number of patients with adverse events, total number and type of adverse events
Time Frame
week 6
Title
Adverse Events
Description
Number of patients with adverse events, total number and type of adverse events
Time Frame
week 12
Other Pre-specified Outcome Measures:
Title
Treatment Expectations
Description
Treatment Credibility Scale (TCS)
Time Frame
week -1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holger Cramer, PhD
Phone
+4920117425015
Email
holger.cramer@bosch-health-campus.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heidemarie Haller, PhD
Phone
+4920172377382
Email
heidemarie.haller@uk-essen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, Prof. MD
Organizational Affiliation
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte
City
Essen
ZIP/Postal Code
45276
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Schäfer, Prof. MD
Phone
+4920117430001
Email
m.schaefer@kem-med.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Whole-body Hyperthermia for Mild to Moderate Depressive Disorder
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