A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia
- Registration Number
- NCT00154258
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Attended the previous Phase IIb (core) study
- Improved during the core study
- No safety issues during the core study
Exclusion Criteria
- Discontinued the core study
- Pregnant or nursing (lactating) women
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 Echo cardiogram at every 24 weeks Baseline to 52 weeks Vital signs at every 4 weeks Baseline to 52 weeks Adverse events during the long term treatment (until NDA approval) 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
- Secondary Outcome Measures
Name Time Method 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