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The study evaluates the effectiveness and safety of Lurasidone in subjects with schizophrenia over a period of 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone 40-160 mg | Experimental | Lurasidone 40-160 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone | Drug | Lurasidone 40-160 mg/day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to treatment failure. | Treatment failure is defined as any occurrence of: Insufficient clinical response Exacerbation of underlying disease Discontinuation due to adverse event | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale(PANSS) total scores | " Mean Change from baseline at week 6" in Positive and Negative Syndrome Scale total scores. The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item.The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei City Hospital, Songde Branch | Taipei | Taiwan | ||||
| Tri-Service General Hospital |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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Lurasidone 40-160 mg/day
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| 6 weeks |
| Clinical Global Impression-Improvement (CGI-I) Scale | " Mean Change from baseline at week 6" in Clinical Global Impression-Improvement. The CGI-I Score is a clinician-rated assessment of the subject's overall clinical condition. The CGI-I score obtained at the baseline (initiation) visit serves as a good basis for making this assessment. This subject's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. | 6 weeks |
| Clinical Global Impression-Severity (CGI-S) | " Mean Change from baseline at week 6" in Clinical Global Impression-Severity. The CGI-S Score is a clinician-rated assessment of the subject's current illness state on a 7-point scale (1-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes. | 6 weeks |
| Taipei |
| Taiwan |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |