Whole-body Hyperthermia for Moderate to Severe Depressive Disorder (HYPE2)
Depression, Unipolar
About this trial
This is an interventional treatment trial for Depression, Unipolar focused on measuring Depression, Hyperthermia, Randomized Controlled Trial
Eligibility Criteria
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
Sites / Locations
- Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-MitteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Whole-body hyperthermia + standard medical care
Standard medical care
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.
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.