Schizophrenia
Conditions
Keywords
Schizophrenia, treatment-resistant, clozapine
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.
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs at every 4 weeks | Baseline to 52 weeks |
| ECG at every 12 weeks | Baseline to 52 weeks |
| Echo cardiogram at every 24 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 |
Secondary
| Measure | Time frame |
|---|---|
| Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks | 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 | Baseline to 52 weeks |
Outcome results
None listed