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A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00154258
Collaborator
(none)
19
Enrollment
1
Arm
104
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia
Study Start Date :
Apr 1, 2001
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Clozapine
Other Names:
  • Clozaril

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events during the long term treatment (until NDA approval) [Baseline to 52 weeks]

    2. Vital signs at every 4 weeks [Baseline to 52 weeks]

    3. Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks) [Baseline to 52 weeks]

    4. ECG at every 12 weeks [Baseline to 52 weeks]

    5. Echo cardiogram at every 24 weeks [Baseline to 52 weeks]

    Secondary Outcome Measures

    1. 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]

    2. Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks [Baseline to 52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts 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 exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Study Chair: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis
    ClinicalTrials.gov Identifier:
    NCT00154258
    Other Study ID Numbers:
    • CLEX123J1202
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Sep 24, 2020
    Last Verified:
    Mar 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis
    Schizophrenia, treatment-resistant, clozapine
    Additional relevant MeSH terms:
    Schizophrenia
    Clozapine

    Study Results

    No Results Posted as of Sep 24, 2020