The Optimal Treatment for Treatment-resistant Schizophrenia

Study Overview
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Brief Summary
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The Optimal Treatment for Treatment-resistant Schizophrenia

Detailed Description
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To explore the curative effect and safety of Risperidone，aripiprazole，sodium valproate，modified electroconvulsive therapy(MECT), or Magnetic seizure therapy(MST) with Clozapine in the treatment of treatment-resistant schizophrenia， and to provide the basis for clinical medication.

Official Title
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The Optimal Treatment for Treatment-resistant Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Risperidone with Clozapine
* Drug: Aripiprazole with Clozapine
* Drug: sodium valproate with Clozapine
* Device: modified electroconvulsive therapy(MECT) with Clozapine
* Device: Magnetic seizure therapy(MST) with Clozapine
* Device: clozapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of schizophrenia according to DSM-V 18～60 years old 2 prior failed treatment trials with 2 different antipsychotics at doses of at least 600 mg/day chlorpromazine equivalents, each of at least 6 weeks duration; Signed an informed consent Exclusion Criteria: patients to be diagnosed according to DSM-V for substance abused, development delayed suffering from serious physical disease and can not accept the treatment MST contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure allergic to risperidone ,aripiprazole, or sodium valproate Participated in any clinical subject within 30 days Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: risperidone with clozapine<br>risperidone, dosage form: 1 mg, dosage and frequency:3.0 6.0 mg/d; clozapine, dosage and frequency:300 600 mg/d; duration: 8 weeks | Drug: Risperidone with Clozapine<br>* Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia<br>* Other names: Risperidone Tablet;|
| Active Comparator: aripiprazole with clozapine<br>aripiprazole, dosage form: 5 mg, dosage and frequency:15 30 mg/day; clozapine, dosage and frequency:300 600 mg/d; duration: 8 weeks | Drug: Aripiprazole with Clozapine<br>* Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia<br>* Other names: Aripiprazole Tablets;|
| Active Comparator: sodium valproate with clozapine<br>sodium valproate, dosage form: 250 mg, dosage and frequency:600 1200 mg/day; clozapine, dosage and frequency:300 600 mg/d; duration: 3 months. | Drug: sodium valproate with Clozapine<br>* sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia<br>* Other names: Valproate;|
| Active Comparator: clozapine<br>only clozapine, dosage and frequency:300 600 mg/d; | Device: clozapine<br>* clozapine may be used in the treatment of treatment-resistant schizophrenia<br>|
| Active Comparator: Modified electroconvulsive therapy with clozapine<br>10 times MECT for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine. | Device: modified electroconvulsive therapy(MECT) with Clozapine<br>* modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia<br>|
| Active Comparator: Magnetic seizure therapy with clozapine<br>10 times MST for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine. | Device: Magnetic seizure therapy(MST) with Clozapine<br>* Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Positive and Negative Syndrome Scale [PANSS] |  | At baseline, 4th week, 8th week,12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in clinical global impression [CGI] |  | At baseline, 4th week, 8th week,12th week | 
| Change from baseline in Simpson-Angus Scale [SAS] |  | At baseline, 4th week, 8th week,12th week | 
| Change from baseline in Abnormal Involuntary Movement Scale[AIMS] |  | At baseline, 4th week, 8th week,12th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia