Schizophrenia
Conditions
Keywords
Schizophrenia, treatment-resistant, clozapine
Brief summary
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.
Detailed description
Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.
Interventions
DRUGClozapine
Sponsors
Novartis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed as schizophrenia * Not responded to at least two atypical antipshychotics launched in Japan * Inpatient
Exclusion criteria
* Low white blood cell count * Significant heart diseases * Diabetes mellitus Other protocol-defined
Design outcomes
Primary
| Measure | 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 | — |
Secondary
| Measure | 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 | — |
Countries
Japan
Outcome results
None listed