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Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.
Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment 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 |
|---|---|---|
| Adverse events during the long term treatment (until NDA approval) | Baseline to 52 weeks | |
| Vital signs at every 4 weeks | Baseline to 52 weeks | |
| Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks) | Baseline to 52 weeks | |
| ECG at every 12 weeks | Baseline to 52 weeks | |
| Echo cardiogram at every 24 weeks | Baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks | Baseline to 52 weeks | |
| Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks | Baseline to 52 weeks |
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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 |
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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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