Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
Overview
- Phase
- Phase 4
- Intervention
- acupuncture
- Conditions
- Schizophrenia
- Sponsor
- Shanghai Mental Health Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The Positive and Negative Syndrome Scale (PANSS)
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Acupuncture
Acupuncture+Amisulpride
Intervention: acupuncture
Acupuncture
Acupuncture+Amisulpride
Intervention: Amisulpride
Amisulpride
Amisulpride only.
Intervention: Amisulpride
Outcomes
Primary Outcomes
The Positive and Negative Syndrome Scale (PANSS)
Time Frame: 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)
Time Frame: the end of 12 weeks
That allows us to measure cognitive impairment in patients.
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Time Frame: the end of 12 weeks
including CAINS self-reported checklists
Secondary Outcomes
- The Temporal Experience of Pleasure Scale (TEPS)(the end of 12 weeks)