Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
acupuncture
Amisulpride
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia ,acupuncture,Amisulpride
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
Sites / Locations
- Shanghai Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Acupuncture
Amisulpride
Arm Description
Acupuncture+Amisulpride
Amisulpride only.
Outcomes
Primary Outcome Measures
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 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 Clinical Assessment Interview for Negative Symptoms (CAINS)
including CAINS and CAINS self-reported checklists
The Clinical Assessment Interview for Negative Symptoms (CAINS)
including CAINS self-reported checklists
Repeatable sets of neuropsychological state measurements (RBANS)
That allows us to measure cognitive impairment in patients.
Repeatable sets of neuropsychological state measurements (RBANS)
That allows us to measure cognitive impairment in patients.
Secondary Outcome Measures
The Temporal Experience of Pleasure Scale (TEPS)
That allows us to measure the experience of pleasure in patients.
The Temporal Experience of Pleasure Scale (TEPS)
That allows us to measure the change of experience of pleasure in patients.
Full Information
NCT ID
NCT03802838
First Posted
January 10, 2019
Last Updated
January 11, 2019
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT03802838
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia ,acupuncture,Amisulpride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
Acupuncture+Amisulpride
Arm Title
Amisulpride
Arm Type
Other
Arm Description
Amisulpride only.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
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'.
Intervention Type
Drug
Intervention Name(s)
Amisulpride
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Positive and Negative Syndrome Scale (PANSS)
Description
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
Time Frame
the baseline
Title
The Positive and Negative Syndrome Scale (PANSS)
Description
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
Time Frame
the end of 12 weeks
Title
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Description
including CAINS and CAINS self-reported checklists
Time Frame
the baseline
Title
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Description
including CAINS self-reported checklists
Time Frame
the end of 12 weeks
Title
Repeatable sets of neuropsychological state measurements (RBANS)
Description
That allows us to measure cognitive impairment in patients.
Time Frame
the baseline
Title
Repeatable sets of neuropsychological state measurements (RBANS)
Description
That allows us to measure cognitive impairment in patients.
Time Frame
the end of 12 weeks
Secondary Outcome Measure Information:
Title
The Temporal Experience of Pleasure Scale (TEPS)
Description
That allows us to measure the experience of pleasure in patients.
Time Frame
the baseline
Title
The Temporal Experience of Pleasure Scale (TEPS)
Description
That allows us to measure the change of experience of pleasure in patients.
Time Frame
the end of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenghui YI
Organizational Affiliation
SHANGHAI MENTAL HEALTH CENTRE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
We'll reach out to this number within 24 hrs