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

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.

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Key information

Conditions

Weight Gain Body Weight Body Weight Changes Mental Disorders Mouth Diseases Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant Sialorrhea Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pacific Neuropsychiatric Specialists, Costa Mesa, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FazaClo (clozapine, USP) ODT

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Azur Pharma, Inc

Industry

Registry information

Official study title

FazaClo Outcomes in the Control of Schizophrenia (FOCUS)

Acronym: FOCUS

Important dates

First posted: May 26, 2008
Registry last updated: Jun 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed