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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
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, treatment-resistant, clozapine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 8, 2005
    Last Updated
    September 22, 2020
    Sponsor
    Novartis
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    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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