Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: acupuncture
* Drug: Amisulpride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of schizophrenia according to International classification diagnosis-10(ICD-10) patients at an age between 18～60 years old of Han nationality Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture<br>Acupuncture+Amisulpride | Device: acupuncture<br>* Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks. These patients were combined with acupuncture. Acupuncture points include:'Yintang', 'Shenting', 'Taiyang', 'Jingming', 'Zanzhu', 'Yuyao', 'Jiaosun', 'Baihui', 'Fengchi', 'Anmian'.<br>Drug: Amisulpride<br>* Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks.<br>|
| Other: Amisulpride<br>Amisulpride only. | Drug: Amisulpride<br>* Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Positive and Negative Syndrome Scale (PANSS) | 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 | the baseline | 
| The Positive and Negative Syndrome Scale (PANSS) | 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 | the end of 12 weeks | 
| The Clinical Assessment Interview for Negative Symptoms (CAINS) | including CAINS and CAINS self-reported checklists | the baseline | 
| The Clinical Assessment Interview for Negative Symptoms (CAINS) | including CAINS self-reported checklists | the end of 12 weeks | 
| Repeatable sets of neuropsychological state measurements (RBANS) | That allows us to measure cognitive impairment in patients. | the baseline | 
| Repeatable sets of neuropsychological state measurements (RBANS) | That allows us to measure cognitive impairment in patients. | the end of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Temporal Experience of Pleasure Scale (TEPS) | That allows us to measure the experience of pleasure in patients. | the baseline | 
| The Temporal Experience of Pleasure Scale (TEPS) | That allows us to measure the change of experience of pleasure in patients. | the end of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia ，acupuncture，Amisulpride