Whole-body Hyperthermia for Mild to Moderate Depressive Disorder
- Conditions
- Depression, Unipolar
- Interventions
- Device: Whole-body hyperthermia
- Registration Number
- NCT03906175
- Lead Sponsor
- Universität Duisburg-Essen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole-body hyperthermia 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.
- Primary Outcome Measures
Name Time Method Depression Severity: clinician-rated week 6 Hamilton Rating Scale for Depression (HAMD-17)
- Secondary Outcome Measures
Name Time Method Global improvement: clinician-rated week 6 Clinical Global Impression Scale (CGI)
Fatigue: patient-rated week 12 Multidimensional Fatigue Inventory (MFI)
Global Improvement: clinician-rated week 12 Clinical Global Impression Scale (CGI)
Stress: patient-rated week 12 Perceived Stress-Scale (PSS)
Biomarkers: tumor necrosis factor alpha week 12 TNF-alpha
Biomarkers: high-sensitivity C-reactive protein week 12 hs-CRP
Biomarkers: tryptophan week 12 tryptophan
Biomarkers: kynurenine week 12 kynurenine
Biomarkers: neopterin week 12 neopterin
Biomarkers: interleukin 2 week 12 IL-2
Depression Severity: clinician-rated week 12 Hamilton Rating Scale for Depression (HAMD-17)
Depression Severity: patient-rated week 12 Beck Depression Inventory II (BDI-II)
Global Functioning: clinician-rated week 12 Global Assessment of Functioning Scale (GAF)
Quality of Life: patient-rated week 12 Short Form Health Survey (SF-12)
Biomarkers: interleukin 6 week 12 IL-6
Biomarkers: interleukin 10 week 12 IL-10
Biomarkers: soluble intercellular adhesion molecule-1 week 12 sICAM-1
Adverse Events week 12 Number of patients with adverse events, total number and type of adverse events
Trial Locations
- Locations (1)
Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte
🇩🇪Essen, Germany