Schizophrenia
Conditions
Keywords
Schizophrenia ，acupuncture，Amisulpride
Brief summary
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
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.
Interventions
DEVICEacupuncture
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'.
DRUGAmisulpride
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.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Positive and Negative Syndrome Scale (PANSS) | the baseline | 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 Clinical Assessment Interview for Negative Symptoms (CAINS) | the baseline | including CAINS and CAINS self-reported checklists |
| Repeatable sets of neuropsychological state measurements (RBANS) | the baseline | That allows us to measure cognitive impairment in patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Temporal Experience of Pleasure Scale (TEPS) | the baseline | That allows us to measure the experience of pleasure in patients. |
Countries
China
Outcome results
None listed