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

Condition(s) targeted: Schizophrenia

Intervention: Clozapine (Drug)

Phase: Phase 2

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 open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.

Official title: An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-Resistant Schizophrenia

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

Primary outcome:

Adverse events during the long term treatment (until NDA approval)

Vital signs at every 4 weeks

Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)

ECG at every 12 weeks

Echo cardiogram at every 24 weeks

Secondary outcome:

Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks

Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks

Detailed 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.

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

Criteria:

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.

Starting date: January 2002
Ending date: June 2009
Last updated: December 19, 2007