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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Active Comparator | Acupuncture+Amisulpride |
|
| Amisulpride | Other | Amisulpride only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | 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'. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhenghui YI | SHANGHAI MENTAL HEALTH CENTRE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000077582 | Amisulpride |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001549 | Benzamides |
| D000577 | Amides |
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|
| Amisulpride | Drug | 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. |
|
| the end of 12 weeks |
| D009930 |
| Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |