Clinical trial NCT00683891: FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey
Official title: FazaClo Outcomes in the Control of Schizophrenia (FOCUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Gain
Sialorrhea
Keywords: FOCUS
Weight gain
Sialorrhea
Treatment refractory schizophrenia
FazaClo
Treatment resistant schizophrenia
clozapine
Hypersalivation
Lead sponsor: Azur Pharma, Inc
Sponsor class: INDUSTRY
First posted: 2008-05-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Clinical changes in body weight in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo
measure: Clinical changes in salivation in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo
Secondary outcomes:
measure: Changes in Clinical Global Impression (CGI) scale when compared to baseline
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Pacific Neuropsychiatric Specialists
state: California
city: Gastonia
country: United States
facility: Gihwala & Associates
state: North Carolina
Study officials:
References: