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Clinical Trials/NCT00250575
NCT00250575
Completed
Phase 3

A 24-week, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Novartis2 sites in 1 country43 target enrollmentNovember 2005
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ConditionsSchizophrenia
InterventionsClozapine

Overview

Phase
Phase 3
Intervention
Clozapine
Conditions
Schizophrenia
Sponsor
Novartis
Enrollment
43
Locations
2
Primary Endpoint
Values of hematological tests during the 24 week treatment
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
December 2009
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Novartis
Responsible Party
Sponsor

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.

Arms & Interventions

1

Intervention: Clozapine

Outcomes

Primary Outcomes

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 Outcomes

  • 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

Study Sites (2)

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