Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Condition(s) studied
Investigational drug(s) / intervention(s)
OLZ/SAM: 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.
Olanzapine: 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
Study summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Eligibility
Primary outcome measure(s)
- Change from baseline in body mass index (BMI) Zscore at week 12 — 12 weeks
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Trial sites (47)
| Facility | City | Region | Status |
|---|---|---|---|
| Alkermes Investigator Site | Dothan | Alabama | Recruiting |
| Alkermes Investigator Site | Little Rock | Arkansas | Recruiting |
| Alkermes Investigator Site | Encino | California | Withdrawn |
| Alkermes Investigator Site | Stanford | California | Recruiting |
| Alkermes Investigator Site | Upland | California | Withdrawn |
| Alkermes Investigator Site | Colorado Springs | Colorado | Withdrawn |
| Alkermes Investigator Site | Denver | Colorado | Active Not Recruiting |
| Alkermes Investigator Site | Hartford | Connecticut | Withdrawn |
| Alkermes Investigator Site | Washington D.C. | District of Columbia | Recruiting |
| Alkermes Investigator Site | Miami | Florida | Withdrawn |
| Alkermes Investigator Site | Miami Lakes | Florida | Recruiting |
| Alkermes Investigator Site | Decatur | Georgia | Recruiting |
| Alkermes Investigator Site | Chicago | Illinois | Recruiting |
| Alkermes Investigator Site | Indianapolis | Indiana | Recruiting |
| Alkermes Investigator Site | Saint Charles | Missouri | Recruiting |
| Alkermes Investigator Site | Lincoln | Nebraska | Recruiting |
| Alkermes Investigator Site | Omaha | Nebraska | Withdrawn |
| Alkermes Investigator Site | Paramus | New Jersey | Withdrawn |
| Alkermes Investigator Site | New York | New York | Recruiting |
| Alkermes Investigational Site | Kinston | North Carolina | Withdrawn |
| Alkermes Investigator Site | Cincinnati | Ohio | Recruiting |
| Alkermes Investigator Site | West Chester | Ohio | Recruiting |
| Alkermes Investigator Site | DeSoto | Texas | Terminated |
| Alkermes Investigator Site | Fort Worth | Texas | Withdrawn |
| Alkermes Investigational Site | Richmond | Virginia | Recruiting |
| Alkermes Investigator Site | Everett | Washington | Recruiting |
| Alkermes Investigator Site | La Plata | Buenos Aires | Recruiting |
| Alkermes Investigator Site | La Plata | Buenos Aires | Recruiting |
| Alkermes Investigator Site | Buenos Aires | Argentina | Recruiting |
| Alkermes Investigator Site | Córdoba | Argentina | Recruiting |
| Alkermes Investigator Site | Mendoza | Argentina | Recruiting |
| Alkermes Investigator Site | Fortaleza | Ceará | Recruiting |
| Alkermes Investigator Site | Curitiba | Paraná | Recruiting |
| Alkermes Investigator Site | Goiânia | Brazil | Recruiting |
| Alkermes Investigator Site | Rio de Janeiro | Brazil | Recruiting |
| Alkermes Investigator Site | São Paulo | Brazil | Recruiting |
| Alkermes Investigator Site | São Paulo | Brazil | Recruiting |
| Alkermes Investigator Site | Barranquilla | Colombia | Recruiting |
| Alkermes Investigator Site | Bello | Colombia | Recruiting |
| Alkermes Investigator Site | Bogotá | Colombia | Active Not Recruiting |
+ 7 more sites — see the full list on the official registry below.
More Alkermes, Inc. trials in Mexico
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05303064 on ClinicalTrials.gov ↗ ← All trials in Mexico