Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
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ClinicalTrials.gov Identifier: NCT03802838 |
Recruitment Status : Unknown
Verified June 2018 by Shanghai Mental Health Center.
Recruitment status was: Enrolling by invitation
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Device: acupuncture Drug: Amisulpride | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Acupuncture
Acupuncture+Amisulpride
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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.
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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. |
- 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
- 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
- The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: the baseline ]including CAINS and CAINS self-reported checklists
- The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: the end of 12 weeks ]including CAINS self-reported checklists
- Repeatable sets of neuropsychological state measurements (RBANS) [ Time Frame: the baseline ]That allows us to measure cognitive impairment in patients.
- Repeatable sets of neuropsychological state measurements (RBANS) [ Time Frame: the end of 12 weeks ]That allows us to measure cognitive impairment in patients.
- The Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: the baseline ]That allows us to measure the experience of pleasure in patients.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802838
China, Shanghai | |
Shanghai Mental Health Center | |
Shanghai, Shanghai, China, 200030 |
Principal Investigator: | Zhenghui YI | SHANGHAI MENTAL HEALTH CENTRE |
Responsible Party: | Shanghai Mental Health Center |
ClinicalTrials.gov Identifier: | NCT03802838 |
Other Study ID Numbers: |
ZHYY-ZXYJHZX-2-201708 |
First Posted: | January 14, 2019 Key Record Dates |
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 |
Schizophrenia ,acupuncture,Amisulpride |
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 |