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Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.
This study is not recruiting in the United States.
Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clozapine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Values of hematological tests during the 24 week treatment | ||
| Incidence of hematological adverse events during the 24 week treatment | ||
| Compliance to Clozapine Patient Monitoring System during the 24 week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the symptoms of psychosis every 4 weeks up to week 24 | ||
| Global change in severity of psychosis at baseline and week 12 | ||
| Global impression of change in the condition of patients at week 12 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Chiba | Japan | ||||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003024 | Clozapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Fukuoka |
| Japan |
| Novartis Investigative Site | Ishikawa | Japan |
| Novartis Investigative Site | Osaka | Japan |
| Novartis Investigative Site | Saga | Japan |
| Novartis Investigative Site | Tokyo | Japan |
| Novartis Investigative Site | Toyama | Japan |
| Novartis Investigative Site | Yamanashi | Japan |