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The Optimal Treatment for Treatment-resistant Schizophrenia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| risperidone with clozapine | Active Comparator | 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 |
|
| aripiprazole with clozapine | Active Comparator | aripiprazole, dosage form: 5 mg, dosage and frequency:15~30 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 8 weeks |
|
| sodium valproate with clozapine | Active Comparator | sodium valproate, dosage form: 250 mg, dosage and frequency:600~1200 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 3 months. |
|
| clozapine | Active Comparator | only clozapine, dosage and frequency:300~600 mg/d; |
|
| Modified electroconvulsive therapy with clozapine | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone with Clozapine | Drug | Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Positive and Negative Syndrome Scale [PANSS] | At baseline, 4th week, 8th week,12th week |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dengtang Liu | Contact | +86 21 64387250-73775 | erliu110@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DTliu | Recruiting | Shanghai | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 31, 2021 | |
| Reset | Apr 27, 2021 | |
| Release | Jan 4, 2024 |
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|
| Magnetic seizure therapy with clozapine | Active Comparator | 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. |
|
|
| Aripiprazole with Clozapine | Drug | Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
|
|
| sodium valproate with Clozapine | Drug | sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
|
|
| modified electroconvulsive therapy(MECT) with Clozapine | Device | modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
|
| Magnetic seizure therapy(MST) with Clozapine | Device | Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
|
| clozapine | Device | clozapine may be used in the treatment of treatment-resistant schizophrenia |
|
| Change from baseline in Abnormal Involuntary Movement Scale[AIMS] |
| At baseline, 4th week, 8th week,12th week |
| Reset | Jun 13, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2021 | Apr 27, 2021 | |||
| Jan 4, 2024 | Jun 13, 2024 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| D003024 | Clozapine |
| D000068180 | Aripiprazole |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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