Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

NCT03802838 | Unknown Phase 4 DMC

• 1 other identifier: ZHYY-ZXYJHZX-2-201708
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia ，acupuncture，Amisulpride

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• The Temporal Experience of Pleasure Scale (TEPS)

  the baseline

• The Temporal Experience of Pleasure Scale (TEPS)

  the end of 12 weeks

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

Acupuncture+Amisulpride

Device: acupuncture; Drug: Amisulpride

Amisulpride

OTHER

Amisulpride only.

Drug: Amisulpride

Interventions

acupuncture DEVICE

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'.

Acupuncture

Amisulpride DRUG

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.

Acupuncture; Amisulpride

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The diagnosis of schizophrenia according to International classification diagnosis-10(ICD-10)
• patients at an age between 18～60 years old of Han nationality

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Acupuncture Therapy; Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Zhenghui YI

  SHANGHAI MENTAL HEALTH CENTRE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: October 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: September 30, 2019
• Last Updated: January 14, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)