A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
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: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Adverse events during the long term treatment (until NDA approval)
Vital signs at every 4 weeks
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
ECG at every 12 weeks
Echo cardiogram at every 24 weeks
Secondary Outcome Measures
Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00154258
Brief Title
A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia
Official Title
An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (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
Adverse events during the long term treatment (until NDA approval)
Time Frame
Baseline to 52 weeks
Title
Vital signs at every 4 weeks
Time Frame
Baseline to 52 weeks
Title
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
Time Frame
Baseline to 52 weeks
Title
ECG at every 12 weeks
Time Frame
Baseline to 52 weeks
Title
Echo cardiogram at every 24 weeks
Time Frame
Baseline to 52 weeks
Secondary Outcome Measure Information:
Title
Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Time Frame
Baseline to 52 weeks
Title
Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Time Frame
Baseline to 52 weeks
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia
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