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

Novartis43 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

ClozapineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (8)

Novartis Investigational Site

Chiba, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Ishikawa, Japan

Novartis Investigative Site

Osaka, Japan

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

Data from ClinicalTrials.gov

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