Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Public ClinicalTrials.gov record NCT04987229. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Study identification
- NCT ID
- NCT04987229
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Alkermes, Inc.
- Industry
- Enrollment
- 236 participants
Conditions and interventions
Conditions
Interventions
- OLZ/SAM Drug
Drug
Eligibility (public fields only)
- Age range
- 10 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2021
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2027
- Last update posted
- May 5, 2026
2021 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alkermes Investigational Site | Dothan | Alabama | 36303 | — |
| Alkermes Investigational Site | Little Rock | Arkansas | 72204 | — |
| Alkermes Investigational Site | Stanford | California | 94305 | — |
| Alkermes Investigator Site | Denver | Colorado | 80202 | — |
| Alkermes Investigational Site | Washington D.C. | District of Columbia | 20010 | — |
| Alkermes Investigational Site | Miami Lakes | Florida | 33016 | — |
| Alkermes Investigational Site | Decatur | Georgia | 30030 | — |
| Alkermes Investigational Site | Chicago | Illinois | 60611 | — |
| Alkermes Investigational Site | Indianapolis | Indiana | 46202 | — |
| Alkermes Investigational Site | Saint Charles | Missouri | 63304 | — |
| Alkermes Investigational Site | Lincoln | Nebraska | 68526 | — |
| Alkermes Investigational Site | Cincinnati | Ohio | 45229 | — |
| Alkermes Investigational Site | West Chester | Ohio | 45069 | — |
| Alkermes Investigational Site | Richmond | Virginia | 23220 | — |
| Alkermes Investigational Site | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04987229, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced May 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04987229 live on ClinicalTrials.gov.