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| Name | Class |
|---|---|
| Janssen Korea, Ltd., Korea | INDUSTRY |
| Ministry of Health, Republic of Korea | OTHER_GOV |
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Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.
Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone
This is a 12-week, randomized, parallel-group, open labeled, flexible-dose study. The patients will be randomized to the risperidone-continuation group in which they continue to receive risperidone, or to the paliperidone-switch group in which they are switched from risperidone to paliperidone. In the paliperidone-switch group, risperidone will be tapered off during the first 4 weeks of the study, while paliperidone is titrated simultaneously. The doses of both drugs will be adjusted according to the clinical judgment of each research psychiatrist, within 6 mg/day of risperidone and 12 mg/day of paliperidone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Paliperidone ER | Experimental | New antipsychotics |
|
| 2 Risperidone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone ER | Drug | 3mg to 12mg of Paliperidone ER once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive function | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | monthly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Sang Yoon, Professor | Dept. of Psychiatry, Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Psychiatry, Chonnam National Univeristy Hospital | Gwangju | 501-757 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22809972 | Derived | Kim SW, Chung YC, Lee YH, Lee JH, Kim SY, Bae KY, Kim JM, Shin IS, Yoon JS. Paliperidone ER versus risperidone for neurocognitive function in patients with schizophrenia: a randomized, open-label, controlled trial. Int Clin Psychopharmacol. 2012 Sep;27(5):267-74. doi: 10.1097/YIC.0b013e328356acad. |
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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 |
|---|---|
| D000068882 | Paliperidone Palmitate |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Risperidone | Drug | 1 to 6 mg of risperidone once or twice a day |
|
|
| D011743 |
| Pyrimidines |
| D011744 | Pyrimidinones |