Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

Schizophrenia Clinical Trial

Official title:

Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03802838
• Other study ID #: ZHYY-ZXYJHZX-2-201708
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: June 2018
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 30, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The Clinical Assessment Interview for Negative Symptoms (CAINS)	including CAINS and CAINS self-reported checklists	the baseline
Primary	The Clinical Assessment Interview for Negative Symptoms (CAINS)	including CAINS self-reported checklists	the end of 12 weeks
Primary	Repeatable sets of neuropsychological state measurements (RBANS)	That allows us to measure cognitive impairment in patients.	the baseline
Primary	Repeatable sets of neuropsychological state measurements (RBANS)	That allows us to measure cognitive impairment in patients.	the end of 12 weeks
Secondary	The Temporal Experience of Pleasure Scale (TEPS)	That allows us to measure the experience of pleasure in patients.	the baseline
Secondary	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