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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-body hyperthermia + standard medical care | Experimental | 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. |
|
| Standard medical care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Severity: clinician-rated | Hamilton Rating Scale for Depression (HAMD-17) | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Severity: clinician-rated | Hamilton Rating Scale for Depression (HAMD-17) | week 1 |
| Depression Severity: clinician-rated | Hamilton Rating Scale for Depression (HAMD-17) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Expectations | Treatment Credibility Scale (TCS) | week -1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, Prof. MD | Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte | Essen | 45276 | Germany |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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. |
|
| week 3 |
| Depression Severity: clinician-rated | Hamilton Rating Scale for Depression (HAMD-17) | week 12 |
| Depression Severity: patient-rated | Beck Depression Inventory II (BDI-II) | week 1 |
| Depression Severity: patient-rated | Beck Depression Inventory II (BDI-II) | week 3 |
| Depression Severity: patient-rated | Beck Depression Inventory II (BDI-II) | week 6 |
| Depression Severity: patient-rated | Beck Depression Inventory II (BDI-II) | week 12 |
| Global improvement: clinician-rated | Clinical Global Impression Scale (CGI) | week 1 |
| Global improvement: clinician-rated | Clinical Global Impression Scale (CGI) | week 3 |
| Global improvement: clinician-rated | Clinical Global Impression Scale (CGI) | week 6 |
| Global improvement: clinician-rated | Clinical Global Impression Scale (CGI) | week 12 |
| Global Functioning: clinician-rated | Global Assessment of Functioning Scale (GAF) | week 1 |
| Global Functioning: clinician-rated | Global Assessment of Functioning Scale (GAF) | week 3 |
| Global Functioning: clinician-rated | Global Assessment of Functioning Scale (GAF) | week 6 |
| Global Functioning: clinician-rated | Global Assessment of Functioning Scale (GAF) | week 12 |
| Fatigue: patient-rated | Multidimensional Fatigue Inventory (MFI) | week 1 |
| Fatigue: patient-rated | Multidimensional Fatigue Inventory (MFI) | week 3 |
| Fatigue: patient-rated | Multidimensional Fatigue Inventory (MFI) | week 6 |
| Fatigue: patient-rated | Multidimensional Fatigue Inventory (MFI) | week 12 |
| Stress: patient-rated | Perceived Stress-Scale (PSS) | week 1 |
| Stress: patient-rated | Perceived Stress-Scale (PSS) | week 3 |
| Stress: patient-rated | Perceived Stress-Scale (PSS) | week 6 |
| Stress: patient-rated | Perceived Stress-Scale (PSS) | week 12 |
| Quality of Life: patient-rated | Short Form Health Survey (SF-12) | week 1 |
| Quality of Life: patient-rated | Short Form Health Survey (SF-12) | week 3 |
| Quality of Life: patient-rated | Short Form Health Survey (SF-12) | week 6 |
| Quality of Life: patient-rated | Short Form Health Survey (SF-12) | week 12 |
| Biomarkers: interleukin 2 | IL-2 | week 1 |
| Biomarkers: interleukin 2 | IL-2 | week 3 |
| Biomarkers: interleukin 2 | IL-2 | week 6 |
| Biomarkers: interleukin 2 | IL-2 | week 12 |
| Biomarkers: interleukin 6 | IL-6 | week 1 |
| Biomarkers: interleukin 6 | IL-6 | week 3 |
| Biomarkers: interleukin 6 | IL-6 | week 6 |
| Biomarkers: interleukin 6 | IL-6 | week 12 |
| Biomarkers: interleukin 10 | IL-10 | week 1 |
| Biomarkers: interleukin 10 | IL-10 | week 3 |
| Biomarkers: interleukin 10 | IL-10 | week 6 |
| Biomarkers: interleukin 10 | IL-10 | week 12 |
| Biomarkers: tumor necrosis factor-alpha | TNF-alpha | week 1 |
| Biomarkers: tumor necrosis factor-alpha | TNF-alpha | week 3 |
| Biomarkers: tumor necrosis factor-alpha | TNF-alpha | week 6 |
| Biomarkers: tumor necrosis factor-alpha | TNF-alpha | week 12 |
| Biomarkers: high-sensitivity C-reactive Protein | hs-CRP | week 1 |
| Biomarkers: high-sensitivity C-reactive Protein | hs-CRP | week 3 |
| Biomarkers: high-sensitivity C-reactive Protein | hs-CRP | week 6 |
| Biomarkers: high-sensitivity C-reactive Protein | hs-CRP | week 12 |
| Biomarkers: soluble intercellular adhesion molecule-1 | sICAM-1 | week 1 |
| Biomarkers: soluble intercellular adhesion molecule-1 | sICAM-1 | week 3 |
| Biomarkers: soluble intercellular adhesion molecule-1 | sICAM-1 | week 6 |
| Biomarkers: soluble intercellular adhesion molecule-1 | sICAM-1 | week 12 |
| Biomarkers: tryptophan | tryptophan | week 1 |
| Biomarkers: tryptophan | tryptophan | week 3 |
| Biomarkers: tryptophan | tryptophan | week 6 |
| Biomarkers: tryptophan | tryptophan | week 12 |
| Biomarkers: kynurenine | kynurenine | week 1 |
| Biomarkers: kynurenine | kynurenine | week 3 |
| Biomarkers: kynurenine | kynurenine | week 6 |
| Biomarkers: kynurenine | kynurenine | week 12 |
| Biomarkers: neopterin | neopterin | week 1 |
| Biomarkers: neopterin | neopterin | week 3 |
| Biomarkers: neopterin | neopterin | week 6 |
| Biomarkers: neopterin | neopterin | week 12 |
| Adverse Events | Number of patients with adverse events, total number and type of adverse events | week 1 |
| Adverse Events | Number of patients with adverse events, total number and type of adverse events | week 3 |
| Adverse Events | Number of patients with adverse events, total number and type of adverse events | week 6 |
| Adverse Events | Number of patients with adverse events, total number and type of adverse events | week 12 |
| D001832 |
| Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |