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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: FazaClo Outcomes in the Control of Schizophrenia (FOCUS)

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.

Detailed Summary:
Sponsor: Azur Pharma, Inc

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Azur Pharma, Inc

Dates:
Date Received: May 22, 2008
Date Started:
Date Completion:
Last Updated: June 18, 2008
Last Verified: June 2008