Clinical trial NCT03802838: Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
Official title: Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia ，acupuncture，Amisulpride
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Positive and Negative Syndrome Scale (PANSS)
timeFrame: the baseline
measure: The Positive and Negative Syndrome Scale (PANSS)
timeFrame: the end of 12 weeks
measure: The Clinical Assessment Interview for Negative Symptoms (CAINS)
timeFrame: the baseline
measure: The Clinical Assessment Interview for Negative Symptoms (CAINS)
timeFrame: the end of 12 weeks
measure: Repeatable sets of neuropsychological state measurements (RBANS)
timeFrame: the baseline
measure: Repeatable sets of neuropsychological state measurements (RBANS)
timeFrame: the end of 12 weeks
Secondary outcomes:
measure: The Temporal Experience of Pleasure Scale (TEPS)
timeFrame: the baseline
measure: The Temporal Experience of Pleasure Scale (TEPS)
timeFrame: the end of 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: SHANGHAI MENTAL HEALTH CENTRE
name: Zhenghui YI
role: PRINCIPAL_INVESTIGATOR
References: