Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

Phase 4

• Conditions: Schizophrenia
• Interventions: Device: acupuncture; Drug: Amisulpride

• Registration Number: NCT03802838
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2018-06
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-11
• Last Update Submitted: 2019-01-11
• Study First Posted: 2019-01-14
• Last Update Posted: 2019-01-14
• Primary Completion: 2019-04-01
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	acupuncture	Acupuncture+Amisulpride
Acupuncture	Amisulpride	Acupuncture+Amisulpride
Amisulpride	Amisulpride	Amisulpride only.

Primary Outcome Measures

Name	Time	Method
The Positive and Negative Syndrome Scale (PANSS)	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)	the end of 12 weeks	That allows us to measure cognitive impairment in patients.
The Clinical Assessment Interview for Negative Symptoms (CAINS)	the end of 12 weeks	including CAINS self-reported checklists

Secondary Outcome Measures

Name	Time	Method
The Temporal Experience of Pleasure Scale (TEPS)	the end of 12 weeks	That allows us to measure the change of experience of pleasure in patients.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China