An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia
Overview
- Phase
- Phase 2
- Intervention
- Clozapine
- Conditions
- Schizophrenia
- Sponsor
- Novartis
- Enrollment
- 19
- Primary Endpoint
- Echo cardiogram at every 24 weeks
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Intervention: Clozapine
Outcomes
Primary Outcomes
Echo cardiogram at every 24 weeks
Time Frame: Baseline to 52 weeks
Vital signs at every 4 weeks
Time Frame: Baseline to 52 weeks
Adverse events during the long term treatment (until NDA approval)
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
Secondary Outcomes
- 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)