Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Whole-body Hyperthermia for Mild to Moderate Depressive Disorder - a Randomized Controlled Tiral

Conditions
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Depression, Unipolar

Intervention / Treatment
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* Device: Whole-body hyperthermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-body hyperthermia<br>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. | Device: Whole-body hyperthermia<br>* 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.<br>|
| No Intervention: Wait list<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Severity: clinician-rated | Hamilton Rating Scale for Depression (HAMD-17) | week 6 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Hyperthermia, Randomized Controlled Trial