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NCT00250575 Clinical Trial

A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00250575
Other study ID # CLEX123J1301
Secondary ID
Status Completed
Phase Phase 3
First received November 7, 2005
Last updated April 20, 2016
Start date November 2005

Study information
Verified date April 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Description:

Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Clozapine

Locations
Country Name City State
Japan Novartis Investigational Site Chiba
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Ishikawa
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Saga
Japan Novartis Investigative Site Tokyo
Japan Novartis Investigative Site Toyama
Japan Novartis Investigative Site Yamanashi

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Values of hematological tests during the 24 week treatment
Primary Incidence of hematological adverse events during the 24 week treatment
Primary Compliance to Clozapine Patient Monitoring System during the 24 week treatment
Secondary Changes in the symptoms of psychosis every 4 weeks up to week 24
Secondary Global change in severity of psychosis at baseline and week 12
Secondary Global impression of change in the condition of patients at week 12 and 24
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