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

This study has been completed.
Sponsor:
Information provided by:
Azur Pharma, Inc
ClinicalTrials.gov Identifier:
NCT00683891
First received: May 22, 2008
Last updated: June 18, 2008
Last verified: June 2008
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine
U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00683891     History of Changes
Other Study ID Numbers: FOCUS
Study First Received: May 22, 2008
Last Updated: June 18, 2008
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

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

ClinicalTrials.gov processed this record on May 22, 2013