Status:
COMPLETED
FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey
Lead Sponsor:
Azur Pharma, Inc
Conditions:
Weight Gain
Sialorrhea
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00683891
Last Update
June 19 2008
Active Locations (2)
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1
Pacific Neuropsychiatric Specialists
Costa Mesa, California, United States, 92626
2
Gihwala & Associates
Gastonia, North Carolina, United States, 28054