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To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 OLZ/SAM | Experimental | Fixed dose combination of olanzapine and samidorphan |
|
| Group 2 Olanzapine | Active Comparator | Fixed dose of olanzapine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OLZ/SAM | Drug | OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body mass index (BMI) Zscore at week 12 | To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12 | To compare subjects with clinical significant BMI Z-score increase with OLZ/SAM vs olanzapine | 12 weeks |
| Time to all-cause discontinuation of study drug over 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Services | Contact | 888-235-8008 (US Only) | clinicaltrials@alkermes.com | |
| Global Clinical Services | Contact | 1-571-599-2702 (Global) | clinicaltrials@alkermes.com |
| Name | Affiliation | Role |
|---|---|---|
| David McDonnell, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigator Site | Recruiting | Dothan | Alabama | 36303 | United States | |
| Alkermes Investigator Site |
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|
|
| Olanzapine | Drug | The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day |
|
To compare time to all-cause discontinuation of study drug with OLZ/SAM vs olanzapine
| Up to 52 weeks |
| Change from baseline in waist circumference | To compare the change from baseline in waist circumference with OLZ/SAM vs olanzapine | 12 weeks |
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit | To compare the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score with OLZ/SAM vs olanzapine for patients with schizophrenia | 12 weeks |
| Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder | To compare the change from baseline in YMRS with OLZ/SAM vs olanzapine for patients with bipolar I disorder | 12 weeks |
| Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit | To compare the change from baseline in CDRS-R with OLZ/SAM vs olanzapine for patients with bipolar I disorder | 12 weeks |
| Incidence of Adverse Events | Up to 52 weeks |
| Recruiting |
| Little Rock |
| Arkansas |
| 72204 |
| United States |
| Alkermes Investigator Site | Withdrawn | Encino | California | 91316 | United States |
| Alkermes Investigator Site | Recruiting | Stanford | California | 94305 | United States |
| Alkermes Investigator Site | Withdrawn | Upland | California | 91786 | United States |
| Alkermes Investigator Site | Withdrawn | Colorado Springs | Colorado | 80910 | United States |
| Alkermes Investigator Site | Active, not recruiting | Denver | Colorado | 80202 | United States |
| Alkermes Investigator Site | Withdrawn | Hartford | Connecticut | 06106 | United States |
| Alkermes Investigator Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Alkermes Investigator Site | Withdrawn | Miami | Florida | 33155 | United States |
| Alkermes Investigator Site | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Alkermes Investigator Site | Recruiting | Decatur | Georgia | 30030 | United States |
| Alkermes Investigator Site | Recruiting | Chicago | Illinois | 60611 | United States |
| Alkermes Investigator Site | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Alkermes Investigator Site | Recruiting | Saint Charles | Missouri | 63304 | United States |
| Alkermes Investigator Site | Recruiting | Lincoln | Nebraska | 68526 | United States |
| Alkermes Investigator Site | Withdrawn | Omaha | Nebraska | 68198 | United States |
| Alkermes Investigator Site | Withdrawn | Paramus | New Jersey | 07652 | United States |
| Alkermes Investigator Site | Recruiting | New York | New York | 10016 | United States |
| Alkermes Investigational Site | Withdrawn | Kinston | North Carolina | 28504 | United States |
| Alkermes Investigator Site | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Alkermes Investigator Site | Recruiting | West Chester | Ohio | 45069 | United States |
| Alkermes Investigator Site | Terminated | DeSoto | Texas | 75115 | United States |
| Alkermes Investigator Site | Withdrawn | Fort Worth | Texas | 76104 | United States |
| Alkermes Investigational Site | Recruiting | Richmond | Virginia | 23220 | United States |
| Alkermes Investigator Site | Recruiting | Everett | Washington | 98201 | United States |
| Alkermes Investigator Site | Recruiting | La Plata | Buenos Aires | 1900 | Argentina |
| Alkermes Investigator Site | Recruiting | La Plata | Buenos Aires | C1199ABB | Argentina |
| Alkermes Investigator Site | Recruiting | Buenos Aires | C1133AAH | Argentina |
| Alkermes Investigator Site | Recruiting | Córdoba | X5003DCE | Argentina |
| Alkermes Investigator Site | Recruiting | Mendoza | 5500 | Argentina |
| Alkermes Investigator Site | Recruiting | Fortaleza | Ceará | 60430-140 | Brazil |
| Alkermes Investigator Site | Recruiting | Curitiba | Paraná | 80240-280 | Brazil |
| Alkermes Investigator Site | Recruiting | Goiânia | 74093-040 | Brazil |
| Alkermes Investigator Site | Recruiting | Rio de Janeiro | 22270-060 | Brazil |
| Alkermes Investigator Site | Recruiting | São Paulo | 01228-000 | Brazil |
| Alkermes Investigator Site | Recruiting | São Paulo | 05403-010 | Brazil |
| Alkermes Investigator Site | Recruiting | Barranquilla | 110121 | Colombia |
| Alkermes Investigator Site | Recruiting | Bello | 51053 | Colombia |
| Alkermes Investigator Site | Recruiting | Bogotá | 111166 | Colombia |
| Alkermes Investigator Site | Recruiting | Bogotá | 80020 | Colombia |
| Alkermes Investigator Site | Recruiting | Pereira | 660003 | Colombia |
| Alkermes Investigator Site | Recruiting | Culiacán | 80230 | Mexico |
| Alkermes Investigator Site | Recruiting | Estado de México | C.P. 07000 | Mexico |
| Alkermes Investigator Site | Recruiting | León | 37000 | Mexico |
| Alkermes Investigator Site | Recruiting | Monterrey | 64620 | Mexico |
| Alkermes Investigator Site | Recruiting | Monterrey | 64710 | Mexico |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000722611 | lybalvi |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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