FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey

Sponsor

Azur Pharma, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00683891

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

AZUR Pharma has received several reports from practicing psychiatrists prescribing FazaClo showing that FazaClo patients start losing body weight instead of keep gaining it, after being switched from other clozapine products or other atypical antipsychotics treatments. Another important clinical observation reported by doctors is a considerable reduction in hypersalivation when FazaClo administration is compared to other antipsychotic treatments. Based on the findings described above, and on the real need for effective and safer treatments for schizophrenia, AZUR Pharma has decided to design and conduct an observational study in a large number of patients taking FazaClo to prove the received clinical reports from physicians. Better understanding and evaluation of these beneficial findings are necessary to provide physicians information for improved treatment decision.

Condition or Disease	Intervention/Treatment	Phase
Weight Gain Sialorrhea	Drug: FazaClo (clozapine, USP) ODT

Study Design

Study Type:

Observational

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

FazaClo Outcomes in the Control of Schizophrenia (FOCUS)

Outcome Measures

Primary Outcome Measures

Clinical changes in body weight in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo []
Clinical changes in salivation in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo []

Secondary Outcome Measures

Changes in Clinical Global Impression (CGI) scale when compared to baseline []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with treatment-resistant schizophrenia currently being treated with Clozaril or generic clozapine for at least 3 months
Patients with treatment-resistant schizophrenia who failed to respond adequately to treatment with at least 2 courses of standard drug treatments for schizophrenia, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs
Males and females of 18 years of age or older
Females of childbearing potential using a reliable form of contraception
Ability to comply with the required WBC/ANC monitoring schedule
Ability to follow physician's instructions
Signed informed consent by patient or legal guardian

Exclusion Criteria:

Phenylketonurics
Females of childbearing potential not using a reliable form of contraception
Women who are pregnant or want to become pregnant
Nursing
Patients allergic to clozapine or any othe ingredient contained in FazaClo tablets
Patients who have previously experienced a severe adverse reaction to clozapine
Patients previously excluded from taking clozapine due to a higher risk of developing white blood cell disorders
Clinical significant medical condition that the physician believes may increase the patient's risk of participating int he study (e.g., severe cardiac disorder, epilepsy)
Concomitant medications that may be contraindicated with FazaClo
Patients who have been taking FazaCLo within the last three months
Patients unable to comply with the required WBC/ANC monitoring schedule
Patients unable to follow the physician's instructions
Patients unable or unwilling to provide Informed Consent