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

This study is ongoing, but not recruiting participants.

First Received: November 7, 2005 Last Updated: December 19, 2007 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00250575

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Clozapine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 24-Week, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-Resistant Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	43
Study Start Date:	October 2005
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
1: Experimental	Drug: Clozapine

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250575

Locations

Japan

Chiba, Japan

Tokyo, Japan

Yamanashi, Japan

Ishikawa, Japan

Saga, Japan

Osaka, Japan

Fukuoka, Japan

Toyama, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLEX123J1301
Study First Received:	November 7, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00250575 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Schizophrenia, treatment-resistant, clozapine

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

GABA Antagonists
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Clozapine
GABA Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009