MedTrace Logo

An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)

NCT07744113 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-08-04

No results posted yet for this study

Summary

To provide continued access to OLZ/SAM for pediatric participants with schizophrenia or bipolar I disorder who have completed participation in the ALKS 3831-A313 long-term safety extension study.

Conditions

  • Bipolar 1 Disorder
  • Schizophrenia Disorder

Interventions

DRUG

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 , 5 mg/day, or 15mg/ day with a maximum daily dose of 20mg/day. The dose of samidorphan will be 10 mg/day.

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744113 on ClinicalTrials.gov