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To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OLZ/SAM | Drug | Olanzapine and Samidorphan fixed dose coated tablet taken once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David McDonnell, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Dothan | Alabama | 36303 | United States | ||
| Alkermes Investigational Site |
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| Little Rock |
| Arkansas |
| 72204 |
| United States |
| Alkermes Investigational Site | Stanford | California | 94305 | United States |
| Alkermes Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| Alkermes Investigational Site | Miami Lakes | Florida | 33016 | United States |
| Alkermes Investigational Site | Decatur | Georgia | 30030 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60611 | United States |
| Alkermes Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Alkermes Investigational Site | Saint Charles | Missouri | 63304 | United States |
| Alkermes Investigational Site | Lincoln | Nebraska | 68526 | United States |
| Alkermes Investigational Site | Cincinnati | Ohio | 45229 | United States |
| Alkermes Investigational Site | West Chester | Ohio | 45069 | United States |
| Alkermes Investigational Site | Richmond | Virginia | 23220 | United States |
| Alkermes Investigational Site | Everett | Washington | 98201 | United States |
| Alkermes Investigational Site | Ciudad Autonoma de Buenos Aire | Buenos Aires | C1181ACH | Argentina |
| Alkermes Investigational Site | La Plata | Buenos Aires | 1900 | Argentina |
| Alkermes Investigational Site | Buenos Aires | Buenos Aires F.D. | C1133AAH | Argentina |
| Alkermes Investigational Site | Mendoza | Mendoza Province | 5500 | Argentina |
| Alkermes Investigational Site | Córdoba | X5003DCE | Argentina |
| Alkermes Investigational Site | Fortaleza | Ceará | 60430-140 | Brazil |
| Alkermes Investigational Site | Curitiba | Paraná | 80240-280 | Brazil |
| Alkermes Investigational Site | Rio de Janeiro | Rio de Janeiro | 22270-060 | Brazil |
| Alkermes Investigational Site | São Paulo | São Paulo | 05403-010 | Brazil |
| Alkermes Investigational Site | Goiânia | 74093-040 | Brazil |
| Alkermes Investigational Site | São Paulo | 01228-000 | Brazil |
| Alkermes Investigational Site | Barranquilla | 110121 | Colombia |
| Alkermes Investigational Site | Bello | 51053 | Colombia |
| Alkermes Investigational Site | Bogotá | 111166 | Colombia |
| Alkermes Investigational Site | Bogotá | 80020 | Colombia |
| Alkermes Investigational Site | Pereira | 660003 | Colombia |
| Alkermes Investigational Site | León | Guanajuato | 37000 | Mexico |
| Alkermes Investigational Site | Monterrey | Nuevo León | 64620 | Mexico |
| Alkermes Investigational Site | Monterrey | Nuevo León | 64710 | Mexico |
| Alkermes Investigational Site | Culiacán | Sinaloa | 80230 | Mexico |
| Alkermes Investigational Site | Gustavo A. Madero | State of Mexico | C.P. 07000 | Mexico |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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