Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Device: acupuncture; Drug: Amisulpride

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acupuncture; Acupuncture+Amisulpride	Device: acupuncture; 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'.; Drug: Amisulpride; 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.
Other: Amisulpride; Amisulpride only.	Drug: Amisulpride; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Positive and Negative Syndrome Scale (PANSS)	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 baseline
The Positive and Negative Syndrome Scale (PANSS)	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 end of 12 weeks
The Clinical Assessment Interview for Negative Symptoms (CAINS)	including CAINS and CAINS self-reported checklists	the baseline
The Clinical Assessment Interview for Negative Symptoms (CAINS)	including CAINS self-reported checklists	the end of 12 weeks
Repeatable sets of neuropsychological state measurements (RBANS)	That allows us to measure cognitive impairment in patients.	the baseline
Repeatable sets of neuropsychological state measurements (RBANS)	That allows us to measure cognitive impairment in patients.	the end of 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Temporal Experience of Pleasure Scale (TEPS)	That allows us to measure the experience of pleasure in patients.	the baseline
The Temporal Experience of Pleasure Scale (TEPS)	That allows us to measure the change of experience of pleasure in patients.	the end of 12 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Zhenghui YI, SHANGHAI MENTAL HEALTH CENTRE

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Schizophrenia ，acupuncture，Amisulpride
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Dopamine Agents; Dopamine Antagonists; Antidepressive Agents, Second-Generation; Amisulpride
• Other Study ID Numbers: ZHYY-ZXYJHZX-2-201708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No