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 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.
Interventions
COMBINATION_PRODUCTWhole-body hyperthermia + standard medical care
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.
COMBINATION_PRODUCTStandard medical care
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.
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) * Moderate depression: 17-23 points on the HAMD-17 or severe depression: ≥24 points on the HAMD-17
Exclusion criteria
* 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: high-sensitivity C-reactive Protein | week 1 | hs-CRP |
| Biomarkers: soluble intercellular adhesion molecule-1 | week 1 | sICAM-1 |
| Biomarkers: tryptophan | week 1 | tryptophan |
| Biomarkers: kynurenine | week 1 | kynurenine |
| Biomarkers: neopterin | week 1 | neopterin |
| Adverse Events | week 1 | Number of patients with adverse events, total number and type of adverse events |
| Depression Severity: clinician-rated | week 1 | Hamilton Rating Scale for Depression (HAMD-17) |
| Biomarkers: tumor necrosis factor-alpha | week 1 | TNF-alpha |
| Global improvement: clinician-rated | week 1 | 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) |
| 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 |
| Depression Severity: patient-rated | week 1 | Beck Depression Inventory II (BDI-II) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Expectations | week -1 | Treatment Credibility Scale (TCS) |
Countries
Germany
Outcome results
None listed