A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
- Registration Number
- NCT00250575
- Lead Sponsor
- Novartis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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 exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Clozapine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Changes in the symptoms of psychosis every 4 weeks up to week 24
Trial Locations
- Locations (2)
Novartis Investigational Site
🇯🇵Chiba, Japan
Novartis Investigative Site
🇯🇵Yamanashi, Japan