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

Novartis

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Clozapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00250575

CLEX123J1301

Details and patient eligibility

About

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.

Full description

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

Enrollment: 43 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Clozapine