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

Novartis

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Clozapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00154258

CLEX123J1202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Clozapine