Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

Shanghai Mental Health Center

Status and phase: Unknown; Phase 4

Conditions: Schizophrenia

Treatments: Device: acupuncture; Drug: Amisulpride

Study type: Interventional

Funder types: Other

Identifiers

NCT03802838

ZHYY-ZXYJHZX-2-201708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Acupuncture

Active Comparator group

Description:

Acupuncture+Amisulpride

Treatment:

Drug: Amisulpride

Device: acupuncture

Amisulpride

Other group

Description:

Amisulpride only.

Treatment:

Drug: Amisulpride