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Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

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

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 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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03802838     History of Changes
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

Keywords provided by Shanghai Mental Health Center:
Schizophrenia ,acupuncture,Amisulpride

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sultopride
Sulpiride
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