A Long Term Study of Clozapine in Patients With Treatment-Resistant Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

December 19, 2007

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00154258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

BPRS, PANSS, DIEPSS and AIMS at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-Resistant Schizophrenia

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.

Study Phase

Phase II

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

Enrollment ^ICMJE

Estimated Completion Date

June 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

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

Administrative Information

NCT ID ^ICMJE

NCT00154258

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CLEX123J1202

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