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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Adverse events during the long term treatment (until NDA approval)
Time frame: Baseline to 52 weeks
Vital signs at every 4 weeks
Time frame: Baseline to 52 weeks
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
Time frame: Baseline to 52 weeks
ECG at every 12 weeks
Time frame: Baseline to 52 weeks
Echo cardiogram at every 24 weeks
Time frame: Baseline to 52 weeks
Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Time frame: Baseline to 52 weeks
Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Time frame: Baseline to 52 weeks
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