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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683891
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : June 19, 2008
Information provided by:
Azur Pharma, Inc

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

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

Resource links provided by the National Library of Medicine

Drug Information available for: Clozapine
U.S. FDA Resources

Primary Outcome Measures :
  1. Clinical changes in body weight in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo
  2. Clinical changes in salivation in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo

Secondary Outcome Measures :
  1. Changes in Clinical Global Impression (CGI) scale when compared to baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683891

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 Identifier: NCT00683891     History of Changes
Other Study ID Numbers: FOCUS
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: June 19, 2008
Last Verified: June 2008

Keywords provided by Azur Pharma, Inc:
Weight gain
Treatment refractory schizophrenia
Treatment resistant schizophrenia

Additional relevant MeSH terms:
Weight Gain
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents