NCT03906175已完成不适用
Whole-body Hyperthermia for Mild to Moderate Depressive Disorder - a Randomized Controlled Tiral
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Depression Severity: clinician-rated
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Whole-body hyperthermia
Experimental
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.
干预措施: Whole-body hyperthermia (Device)
Wait list
No Intervention
Participants will wait for 6 weeks (primary outcome assessment point). They will then receive the same treatment procedure as the experimental group. They will also be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia.
结局指标
主要结局
Depression Severity: clinician-rated
时间窗: week 6
Hamilton Rating Scale for Depression (HAMD-17)
次要结局
- Quality of Life: patient-rated(week 12)
- Global improvement: clinician-rated(week 6)
- Fatigue: patient-rated(week 12)
- Global Improvement: clinician-rated(week 12)
- Stress: patient-rated(week 12)
- Biomarkers: tumor necrosis factor alpha(week 12)
- Biomarkers: high-sensitivity C-reactive protein(week 12)
- Biomarkers: tryptophan(week 12)
- Biomarkers: kynurenine(week 12)
- Biomarkers: neopterin(week 12)
- Biomarkers: interleukin 2(week 12)
- Depression Severity: clinician-rated(week 12)
- Depression Severity: patient-rated(week 12)
- Global Functioning: clinician-rated(week 12)
- Biomarkers: interleukin 6(week 12)
- Biomarkers: interleukin 10(week 12)
- Biomarkers: soluble intercellular adhesion molecule-1(week 12)
- Adverse Events(week 12)
- Biomarkers: interleukin 2(week 3)
- Biomarkers: interleukin 2(week 6)
- Stress: patient-rated(week 1)
- Depression Severity: clinician-rated(week 1)
- Biomarkers: interleukin 10(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 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 3)
- 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 6(week 1)
- Biomarkers: interleukin 6(week 3)
- Biomarkers: interleukin 6(week 6)
- 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)
研究者
Holger Cramer
Research Director
Universität Duisburg-Essen
研究点 (1)
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