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

Tracking Information

First Received Date ^ICMJE

November 7, 2005

Last Updated Date

December 19, 2007

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00250575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Change in BPRS score every 4 weeks up to week 24
CGI-S at baseline and week 12
CGI-C at weeks 12 and 24

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A 24-Week, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-Resistant Schizophrenia

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Clozapine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00250575

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CLEX123J1301

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP