NCT02690324Unknown不适用
The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Electrodermal activity(EDA)
研究概览
简要总结
development of skin adhesive patches for the monitoring and prediction of mental disorders
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the existence of a current Major depressive disorder or panic disorder during the screening and baseline visits, per the Mini-International Neuropsychiatric Interview (Sheehan et al., 1998) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •scored at least 16 on the HDRS-17 (Hamilton, 1960) for MDD and 7 on the Panic disorder severity scale for panic disorder patients at the baseline visits.
排除标准
- •Patients who had psychotic disorder (e.g., schizophrenia or delusional disorder), bipolar affective disorder,active alcohol or drug use disorder, neurological illness including significant cognitive impairment or Parkinson's disease, mental retardation, significant medical conditions, epilepsy, histories of alcohol or drug dependence, personality disorders, or brain damages
- •patients who were at serious risk for suicide of homicide
研究组 & 干预措施
Major depressive disorder
Experimental
DSM-5 major depressive disorder HAMD-17 > 16
干预措施: cognitive stress (serial 7) (Behavioral)
panic disorder
Active Comparator
DSM-5 panic disorder PDSS>7
干预措施: cognitive stress (serial 7) (Behavioral)
normal control
Active Comparator
age >20, healthy adults HAMD-17<17 PDSS<7
干预措施: cognitive stress (serial 7) (Behavioral)
结局指标
主要结局
Electrodermal activity(EDA)
时间窗: baseline, 0.5, 1,2,3 months
changes of skin conductane level(SCL) and skin conductance response(SCR)
Heart rate variability
时间窗: baseline, 0.5, 1,2,3 months
changes of SDNN, RMSSD and LF/HF ratio
次要结局
- Epinephrine(baseline, 0.5, 1,2,3 months)
- Adiponectin(baseline, 0.5, 1,2,3 months)
- APPQ(Albany Panic and Phobia Questionnaire)(baseline, 0.5, 1,2,3 months)
- Panic disorder severity scale(PDSS)(baseline, 0.5, 1,2,3 months)
- Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met(baseline, 0.5, 1,2,3 months)
- BDNF(baseline, 0.5, 1,2,3 months)
- MINI plus(Baseline)
- MINI Suicidality Module(baseline, 0.5, 1,2,3 months)
- Hamilton Depression Rating Scale-17(HAMD-17)(baseline, 0.5, 1,2,3 months)
- Anxiety Sensitivity Index(ASI)(baseline, 0.5, 1,2,3 months)
- Hamilton Anxiety Rating Scale(HAMA)(baseline, 0.5, 1,2,3 months)
- PSWQ(Penn state worry questionnaire)(baseline, 0.5, 1,2,3 months)
- SRI(Stress response Inventory)(baseline, 0.5, 1,2,3 months)
- Perceived Stress Scale(PSS)(baseline, 0.5, 1,2,3 months)
- Barratt Impulsivity Scale(baseline, 0.5, 1,2,3 months)
- Cytokines(baseline, 0.5, 1,2,3 months)
- Norepinephrine(baseline, 0.5, 1,2,3 months)
- C reactive protein(baseline, 0.5, 1,2,3 months)
- Leptin(baseline, 0.5, 1,2,3 months)
研究者
研究点 (1)
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