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

Condition(s) targeted: Schizophrenia

Intervention: Clozapine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis

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.

Official title: A 24-Week, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-Resistant Schizophrenia

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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:

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

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

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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.

Chiba, Japan

Tokyo, Japan

Yamanashi, Japan

Ishikawa, Japan

Toyama, Japan

Osaka, Japan

Fukuoka, Japan

Saga, Japan

Starting date: October 2005
Ending date: June 2009
Last updated: December 19, 2007