Whole-body Hyperthermia for Mild to Moderate Depressive Disorder (HYPE1)
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ClinicalTrials.gov Identifier: NCT03906175 |
Recruitment Status :
Recruiting
First Posted : April 8, 2019
Last Update Posted : November 15, 2021
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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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | June 11, 2019 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | June 2023 |

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.
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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.
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- Depression Severity: clinician-rated [ Time Frame: week 6 ]Hamilton Rating Scale for Depression (HAMD-17)
- 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
- Treatment Expectations [ Time Frame: week -1 ]Treatment Credibility Scale (TCS)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906175
Contact: Holger Cramer, PhD | +4920117425015 | h.cramer@kem-med.com | |
Contact: Heidemarie Haller, PhD | +4920117425044 | h.haller@kem-med.com |
Germany | |
Department of Psychiatry, Psychotherapy and Addiciton Medicine, Kliniken Essen-Mitte | Recruiting |
Essen, Germany, 45276 | |
Contact: Martin Schäfer, Prof. MD +4920117430001 m.schaefer@kem-med.com |
Study Director: | Gustav Dobos, Prof. MD | Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Germany |
Responsible Party: | Holger Cramer, Research Director, Universität Duisburg-Essen |
ClinicalTrials.gov Identifier: | NCT03906175 |
Other Study ID Numbers: |
18-8439-BO |
First Posted: | April 8, 2019 Key Record Dates |
Last Update Posted: | November 15, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Depression Hyperthermia Randomized Controlled Trial |
Hyperthermia Fever Depression Depressive Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Body Temperature Changes Heat Stress Disorders Wounds and Injuries |