NCT03906149已完成不适用
Whole-body Hyperthermia for Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 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 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.
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)
- •Moderate depression: 17-23 points on the HAMD-17 or severe depression: ≥24 points on the HAMD-17
排除标准
- •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
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
- 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)
研究者
Holger Cramer
Research Director
Universität Duisburg-Essen
研究点 (2)
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