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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FazaClo (clozapine, USP) ODT | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Clinical Global Impression (CGI) scale when compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Neuropsychiatric Specialists | Costa Mesa | California | 92626 | United States | ||
| Gihwala & Associates |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D012798 | Sialorrhea |
| D000090663 | Schizophrenia, Treatment-Resistant |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003024 | Clozapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Gastonia |
| North Carolina |
| 28054 |
| United States |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |