Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Public ClinicalTrials.gov record NCT05303064. 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
A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)
Study identification
- NCT ID
- NCT05303064
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Alkermes, Inc.
- Industry
- Enrollment
- 220 participants
Conditions and interventions
Conditions
Interventions
- OLZ/SAM Drug
- Olanzapine 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
- Jun 29, 2022
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
- Last update posted
- May 5, 2026
2022 – 2026
United States locations
- U.S. sites
- 26
- U.S. states
- 19
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alkermes Investigator Site | Dothan | Alabama | 36303 | Recruiting |
| Alkermes Investigator Site | Little Rock | Arkansas | 72204 | Recruiting |
| Alkermes Investigator Site | Encino | California | 91316 | Withdrawn |
| Alkermes Investigator Site | Stanford | California | 94305 | Recruiting |
| Alkermes Investigator Site | Upland | California | 91786 | Withdrawn |
| Alkermes Investigator Site | Colorado Springs | Colorado | 80910 | Withdrawn |
| Alkermes Investigator Site | Denver | Colorado | 80202 | Active, not recruiting |
| Alkermes Investigator Site | Hartford | Connecticut | 06106 | Withdrawn |
| Alkermes Investigator Site | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Alkermes Investigator Site | Miami | Florida | 33155 | Withdrawn |
| Alkermes Investigator Site | Miami Lakes | Florida | 33016 | Recruiting |
| Alkermes Investigator Site | Decatur | Georgia | 30030 | Recruiting |
| Alkermes Investigator Site | Chicago | Illinois | 60611 | Recruiting |
| Alkermes Investigator Site | Indianapolis | Indiana | 46202 | Recruiting |
| Alkermes Investigator Site | Saint Charles | Missouri | 63304 | Recruiting |
| Alkermes Investigator Site | Lincoln | Nebraska | 68526 | Recruiting |
| Alkermes Investigator Site | Omaha | Nebraska | 68198 | Withdrawn |
| Alkermes Investigator Site | Paramus | New Jersey | 07652 | Withdrawn |
| Alkermes Investigator Site | New York | New York | 10016 | Not yet recruiting |
| Alkermes Investigational Site | Kinston | North Carolina | 28504 | Withdrawn |
| Alkermes Investigator Site | Cincinnati | Ohio | 45219 | Recruiting |
| Alkermes Investigator Site | West Chester | Ohio | 45069 | Recruiting |
| Alkermes Investigator Site | DeSoto | Texas | 75115 | Terminated |
| Alkermes Investigator Site | Fort Worth | Texas | 76104 | Withdrawn |
| Alkermes Investigational Site | Richmond | Virginia | 23220 | Recruiting |
| Alkermes Investigator Site | Everett | Washington | 98201 | Recruiting |
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 NCT05303064, 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 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05303064 live on ClinicalTrials.gov.