NCT03906149CompletedNot Applicable
Whole-body Hyperthermia for Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Depression Severity: clinician-rated
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Whole-body hyperthermia + standard medical care
Experimental
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.
Intervention: Whole-body hyperthermia + standard medical care (Combination Product)
Standard medical care
Active Comparator
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.
Intervention: Standard medical care (Combination Product)
Outcomes
Primary Outcomes
Depression Severity: clinician-rated
Time Frame: week 6
Hamilton Rating Scale for Depression (HAMD-17)
Secondary Outcomes
- Depression Severity: patient-rated(week 12)
- Global Functioning: clinician-rated(week 12)
- Quality of Life: patient-rated(week 12)
- Depression Severity: clinician-rated(week 12)
- Stress: patient-rated(week 12)
- Biomarkers: high-sensitivity C-reactive Protein(week 12)
- Biomarkers: tryptophan(week 12)
- Global improvement: clinician-rated(week 12)
- Fatigue: patient-rated(week 12)
- Biomarkers: tumor necrosis factor-alpha(week 12)
- Biomarkers: kynurenine(week 12)
- Adverse Events(week 12)
- Biomarkers: neopterin(week 12)
- Biomarkers: interleukin 2(week 12)
- Biomarkers: interleukin 6(week 12)
- Biomarkers: interleukin 10(week 12)
- Biomarkers: soluble intercellular adhesion molecule-1(week 12)
- Biomarkers: interleukin 6(week 3)
- Stress: patient-rated(week 3)
- Depression Severity: clinician-rated(week 1)
- Depression Severity: clinician-rated(week 3)
- Depression Severity: patient-rated(week 1)
- Depression Severity: patient-rated(week 3)
- Depression Severity: patient-rated(week 6)
- Global improvement: clinician-rated(week 1)
- Global improvement: clinician-rated(week 3)
- Global improvement: clinician-rated(week 6)
- Global Functioning: clinician-rated(week 1)
- Global Functioning: clinician-rated(week 3)
- Global Functioning: clinician-rated(week 6)
- Fatigue: patient-rated(week 1)
- Fatigue: patient-rated(week 3)
- Fatigue: patient-rated(week 6)
- Stress: patient-rated(week 1)
- Stress: patient-rated(week 6)
- Quality of Life: patient-rated(week 1)
- Quality of Life: patient-rated(week 3)
- Quality of Life: patient-rated(week 6)
- Biomarkers: interleukin 2(week 1)
- Biomarkers: interleukin 2(week 3)
- Biomarkers: interleukin 2(week 6)
- Biomarkers: interleukin 6(week 1)
- Biomarkers: interleukin 6(week 6)
- Biomarkers: interleukin 10(week 1)
- Biomarkers: interleukin 10(week 3)
- Biomarkers: interleukin 10(week 6)
- Biomarkers: tumor necrosis factor-alpha(week 1)
- Biomarkers: tumor necrosis factor-alpha(week 3)
- Biomarkers: tumor necrosis factor-alpha(week 6)
- Biomarkers: high-sensitivity C-reactive Protein(week 1)
- Biomarkers: high-sensitivity C-reactive Protein(week 3)
- Biomarkers: high-sensitivity C-reactive Protein(week 6)
- Biomarkers: soluble intercellular adhesion molecule-1(week 1)
- Biomarkers: soluble intercellular adhesion molecule-1(week 3)
- Biomarkers: soluble intercellular adhesion molecule-1(week 6)
- Biomarkers: tryptophan(week 1)
- Biomarkers: tryptophan(week 3)
- Biomarkers: tryptophan(week 6)
- Biomarkers: kynurenine(week 1)
- Biomarkers: kynurenine(week 3)
- Biomarkers: kynurenine(week 6)
- Biomarkers: neopterin(week 1)
- Biomarkers: neopterin(week 3)
- Biomarkers: neopterin(week 6)
- Adverse Events(week 1)
- Adverse Events(week 3)
- Adverse Events(week 6)
Investigators
Holger Cramer
Research Director
Universität Duisburg-Essen
Study Sites (1)
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