Back to resultsA Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Clozapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, treatment-resistant, clozapine
Eligibility 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.
Sites / Locations
- Novartis Investigational Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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
Changes in the symptoms of psychosis every 4 weeks up to week 24
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00250575
Brief Title
A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
Official Title
A 24-week, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, treatment-resistant, clozapine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clozapine
Other Intervention Name(s)
Clozaril
Primary Outcome Measure Information:
Title
Values of hematological tests during the 24 week treatment
Title
Incidence of hematological adverse events during the 24 week treatment
Title
Compliance to Clozapine Patient Monitoring System during the 24 week treatment
Secondary Outcome Measure Information:
Title
Changes in the symptoms of psychosis every 4 weeks up to week 24
Title
Global change in severity of psychosis at baseline and week 12
Title
Global impression of change in the condition of patients at week 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigational Site
City
Chiba
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
Country
Japan
Facility Name
Novartis Investigative Site
City
Ishikawa
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
Country
Japan
Facility Name
Novartis Investigative Site
City
Saga
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokyo
Country
Japan
Facility Name
Novartis Investigative Site
City
Toyama
Country
Japan
Facility Name
Novartis Investigative Site
City
Yamanashi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
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