Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
To explore the effects of combined traditional Chinese and Western medicine( Chinese acupuncture combined with Amisulpride Tablets) on negative symptoms, cognitive function and social function in patients with schizophrenia, and the side effects and safety of Chinese acupuncture combined with Amisulpride Tablets.
详细描述
Our research hypothesis：1. Medically assisted Acupuncture in schizophrenia can improve negative symptoms；2. Drug assisted Acupuncture Therapy has better cognitive function in schizophrenic patients than single drug；3. Schizophrene with acupuncture have fewer and lighter adverse reactions。This study was carried out only in Shanghai Mental Health Center. It was a parallel randomized study.Schizophrene with negative symptoms were treated with atypical antipsychotic drug amisulpride, but still remained negative symptoms. Using the mature Chinese medicine therapy acupuncture auxiliary treatment, using the more reliable clinical evaluation method (the grader blind method: The raters were not sure which patients were the study group or the control group), compared with the single drug treatment, To observe the changes of negative symptoms and cognitive function, and the incidence of adverse reactions of acupuncture therapy, to explore the "new" auxiliary means for the treatment of negative symptoms, to guide clinical individualization and accurate medical treatment.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of schizophrenia according to International classification diagnosis-10(ICD-10)
- •patients at an age between 18～60 years old of Han nationality
排除标准
- •other psychiatric diagnoses
- •Suffering from serious physical disease and can not accept the treatment
- •Patients to be diagnosed according to ICD-10 for substance abused, development delayed
- •Inability to sign informed consent because of capacity due due to severe mental illness, significant psychomotor agitation or slowness test completion
- •claustrophobic
- •metal implantation in vivo
研究组 & 干预措施
Acupuncture
Acupuncture+Amisulpride
干预措施: acupuncture (Device)
Acupuncture
Acupuncture+Amisulpride
干预措施: Amisulpride (Drug)
Amisulpride
Amisulpride only.
干预措施: Amisulpride (Drug)
结局指标
主要结局
The Positive and Negative Syndrome Scale (PANSS)
时间窗: the end of 12 weeks
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale
Repeatable sets of neuropsychological state measurements (RBANS)
时间窗: the end of 12 weeks
That allows us to measure cognitive impairment in patients.
The Clinical Assessment Interview for Negative Symptoms (CAINS)
时间窗: the end of 12 weeks
including CAINS self-reported checklists
次要结局
- The Temporal Experience of Pleasure Scale (TEPS)(the end of 12 weeks)