Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

• ClinicalTrials.gov Identifier: NCT03802838
• Recruitment Status: Unknown
• First Posted: January 14, 2019
• Last Update Posted: January 14, 2019
• Sponsor: Shanghai Mental Health Center
• Information provided by (Responsible Party): Shanghai Mental Health Center

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Device: acupuncture; Drug: Amisulpride	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
• Actual Study Start Date: October 1, 2017
• Estimated Primary Completion Date: April 1, 2019
• Estimated Study Completion Date: September 30, 2019

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. The Positive and Negative Syndrome Scale (PANSS) [ Time Frame: the baseline ]
   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
2. The Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 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
3. The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: the baseline ]
   including CAINS and CAINS self-reported checklists
4. The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: the end of 12 weeks ]
   including CAINS self-reported checklists
5. Repeatable sets of neuropsychological state measurements (RBANS) [ Time Frame: the baseline ]
   That allows us to measure cognitive impairment in patients.
6. Repeatable sets of neuropsychological state measurements (RBANS) [ Time Frame: the end of 12 weeks ]
   That allows us to measure cognitive impairment in patients.

Secondary Outcome Measures :

1. The Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: the baseline ]
   That allows us to measure the experience of pleasure in patients.
2. The Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: the end of 12 weeks ]
   That allows us to measure the change of experience of pleasure in patients.

Eligibility Criteria

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

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

Contacts and Locations

Locations

China, Shanghai

Shanghai Mental Health Center

Shanghai, Shanghai, China, 200030

Sponsors and Collaborators

Shanghai Mental Health Center

Investigators

• Principal Investigator: Zhenghui YI; SHANGHAI MENTAL HEALTH CENTRE

More Information

• Responsible Party: Shanghai Mental Health Center
• ClinicalTrials.gov Identifier: NCT03802838
• Other Study ID Numbers: ZHYY-ZXYJHZX-2-201708
• First Posted: January 14, 2019
• Last Update Posted: January 14, 2019
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Mental Health Center:

Schizophrenia ，acupuncture，Amisulpride

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Amisulpride; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antidepressive Agents, Second-Generation; Antidepressive Agents