Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Enrolling by invitation Phase 3 Interventional

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

ClinicalTrials.gov ID: NCT04987229

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.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 12:37 PM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To evaluate the long-term safety and tolerability 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

Interventions

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 22, 2021 (Actual)
Primary completion
Sep 2027 (Estimated)
Completion
Sep 2027 (Estimated)
Last update posted
Aug 14, 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 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 Investigator Site New York New York 10016 —
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 20 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 Aug 14, 2026 · Synced Oct 22, 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 public registry record, listed eligibility criteria, and available contact information for NCT04987229 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →