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

Study Overview
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Brief Summary
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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.

Official Title
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FazaClo Outcomes in the Control of Schizophrenia (FOCUS)

Conditions
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Weight Gain, Sialorrhea

Intervention / Treatment
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* Drug: FazaClo (clozapine, USP) ODT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FazaClo (clozapine, USP) ODT|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Clinical Global Impression (CGI) scale when compared to baseline |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FOCUS, Weight gain, Sialorrhea, Treatment refractory schizophrenia, FazaClo, Treatment resistant schizophrenia, clozapine, Hypersalivation