Depression, Unipolar
Conditions
Keywords
Depression, Hyperthermia, Randomized Controlled Trial
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.
Interventions
DEVICEWhole-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.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity: clinician-rated | week 6 | Hamilton Rating Scale for Depression (HAMD-17) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers: soluble intercellular adhesion molecule-1 | week 1 | sICAM-1 |
| Biomarkers: tryptophan | week 1 | tryptophan |
| Depression Severity: clinician-rated | week 1 | Hamilton Rating Scale for Depression (HAMD-17) |
| Depression Severity: patient-rated | week 1 | Beck Depression Inventory II (BDI-II) |
| Global improvement: clinician-rated | week 1 | Clinical Global Impression Scale (CGI) |
| Global Improvement: clinician-rated | week 12 | Clinical Global Impression Scale (CGI) |
| Global Functioning: clinician-rated | week 1 | Global Assessment of Functioning Scale (GAF) |
| Fatigue: patient-rated | week 1 | Multidimensional Fatigue Inventory (MFI) |
| Biomarkers: kynurenine | week 1 | kynurenine |
| Adverse Events | week 1 | Number of patients with adverse events, total number and type of adverse events |
| Stress: patient-rated | week 1 | Perceived Stress-Scale (PSS) |
| Quality of Life: patient-rated | week 1 | Short Form Health Survey (SF-12) |
| Biomarkers: interleukin 2 | week 1 | IL-2 |
| Biomarkers: interleukin 6 | week 1 | IL-6 |
| Biomarkers: interleukin 10 | week 1 | IL-10 |
| Biomarkers: tumor necrosis factor alpha | week 1 | TNF-alpha |
| Biomarkers: high-sensitivity C-reactive protein | week 1 | hs-CRP |
| Biomarkers: neopterin | week 1 | neopterin |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Expectations | week -1 | Treatment Credibility Scale (TCS) |
Countries
Germany
Outcome results
None listed