A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Clozapine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals
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.
Clinical Details
Official title: A 24-week, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Values of hematological tests during the 24 week treatmentIncidence of hematological adverse events during the 24 week treatment Compliance to Clozapine Patient Monitoring System during the 24 week treatment
Secondary outcome: Changes in the symptoms of psychosis every 4 weeks up to week 24Global change in severity of psychosis at baseline and week 12 Global impression of change in the condition of patients at week 12 and 24
Detailed description:
Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of
clozapine in patients with treatment-resistant schizophrenia.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Novartis Investigational Site, Chiba, Japan
Novartis Investigative Site, Fukuoka, Japan
Novartis Investigative Site, Ishikawa, Japan
Novartis Investigative Site, Osaka, Japan
Novartis Investigative Site, Saga, Japan
Novartis Investigative Site, Tokyo, Japan
Novartis Investigative Site, Toyama, Japan
Novartis Investigative Site, Yamanashi, Japan
Additional Information
Starting date: November 2005
Last updated: May 3, 2012
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