FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey - Full Text View

Sponsored by:	Azur Pharma, Inc
Information provided by:	Azur Pharma, Inc
ClinicalTrials.gov Identifier:	NCT00683891

Purpose

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	Intervention
Weight Gain Sialorrhea	Drug: FazaClo (clozapine, USP) ODT

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	FazaClo Outcomes in the Control of Schizophrenia (FOCUS)

Further study details as provided by Azur Pharma, Inc:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The enrolled population consists of male and female patients with treatment-resistant schizophrenia of 18 years of age or older, already taking Clozaril (clozapine) or generic clozapine, or patients with treatment-resistant schizophrenia who have failed on other atypical antipsychotic drugs.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683891

Locations

United States, California
Pacific Neuropsychiatric Specialists
Costa Mesa, California, United States, 92626
United States, North Carolina
Gihwala & Associates
Gastonia, North Carolina, United States, 28054

Sponsors and Collaborators

Azur Pharma, Inc

More Information

Study ID Numbers:	FOCUS
Study First Received:	May 22, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00683891
Health Authority:	United States: Institutional Review Board

Keywords provided by Azur Pharma, Inc:

FOCUS
Weight gain
Sialorrhea
Treatment refractory schizophrenia

FazaClo
Treatment resistant schizophrenia
clozapine
Hypersalivation

Study placed in the following topic categories:

Mouth Diseases
Sialorrhea
Weight Gain
Serotonin
Body Weight
Schizophrenia
Signs and Symptoms

Mental Disorders
Clozapine
Body Weight Changes
Psychotic Disorders
Stomatognathic Diseases
Salivary Gland Diseases
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents

Pharmacologic Actions
GABA Antagonists
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
GABA Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009