- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683891
FazaClo Outcomes in the Control of Schizophrenia (FOCUS) Study Survey (FOCUS)
June 18, 2008 updated by: Azur Pharma, Inc
FazaClo Outcomes in the Control of Schizophrenia (FOCUS)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Costa Mesa, California, United States, 92626
- Pacific Neuropsychiatric Specialists
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North Carolina
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Gastonia, North Carolina, United States, 28054
- Gihwala & Associates
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical changes in body weight in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo
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Clinical changes in salivation in patients with treatment-resistant schizophrenia after initiating treatment with FazaClo
|
Secondary Outcome Measures
Outcome Measure |
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Changes in Clinical Global Impression (CGI) scale when compared to baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
May 22, 2008
First Submitted That Met QC Criteria
May 23, 2008
First Posted (Estimate)
May 26, 2008
Study Record Updates
Last Update Posted (Estimate)
June 19, 2008
Last Update Submitted That Met QC Criteria
June 18, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Body Weight
- Schizophrenia Spectrum and Other Psychotic Disorders
- Stomatognathic Diseases
- Mouth Diseases
- Body Weight Changes
- Salivary Gland Diseases
- Schizophrenia
- Weight Gain
- Sialorrhea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- GABA Agents
- GABA Antagonists
- Clozapine
Other Study ID Numbers
- FOCUS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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