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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

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.

Detailed Description

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Conditions

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Weight Gain Sialorrhea

Keywords

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FOCUS Weight gain Sialorrhea Treatment refractory schizophrenia FazaClo Treatment resistant schizophrenia clozapine Hypersalivation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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FazaClo (clozapine, USP) ODT

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Pacific Neuropsychiatric Specialists

Costa Mesa, California, United States

Site Status

Gihwala & Associates

Gastonia, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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FOCUS

Identifier Type: -

Identifier Source: org_study_id