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

August 12, 2026 updated by: Alkermes, Inc.

Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5003DCE
        • Alkermes Investigational Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1181ACH
        • Alkermes Investigational Site
      • La Plata, Buenos Aires, Argentina, 1900
        • Alkermes Investigational Site
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1133AAH
        • Alkermes Investigational Site
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentina, 5500
        • Alkermes Investigational Site
  • Brazil
      • Goiânia, Brazil, 74093-040
        • Alkermes Investigational Site
      • São Paulo, Brazil, 01228-000
        • Alkermes Investigational Site
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-140
        • Alkermes Investigational Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80240-280
        • Alkermes Investigational Site
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22270-060
        • Alkermes Investigational Site
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-010
        • Alkermes Investigational Site
  • Colombia
      • Barranquilla, Colombia, 110121
        • Alkermes Investigational Site
      • Bello, Colombia, 51053
        • Alkermes Investigational Site
      • Bogotá, Colombia, 80020
        • Alkermes Investigational Site
      • Pereira, Colombia, 660003
        • Alkermes Investigational Site
  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Alkermes Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64620
        • Alkermes Investigational Site
      • Monterrey, Nuevo León, Mexico, 64710
        • Alkermes Investigational Site
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Alkermes Investigational Site
    • State of Mexico
      • Gustavo A. Madero, State of Mexico, Mexico, C.P. 07000
        • Alkermes Investigational Site
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Alkermes Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Alkermes Investigational Site
    • California
      • Stanford, California, United States, 94305
        • Alkermes Investigational Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Alkermes Investigational Site
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Alkermes Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Alkermes Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Alkermes Investigational Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Alkermes Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Alkermes Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Alkermes Investigator Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Alkermes Investigational Site
      • West Chester, Ohio, United States, 45069
        • Alkermes Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Alkermes Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion.
  • Subject will benefit from continued therapy with OLZ/SAM per clinical judgment.
  • Subject is able to be treated on an outpatient basis.
  • Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient.
  • Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
  • Subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study.

Exclusion Criteria:

  • Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior since the last visit.
  • Subject has any finding that in the view of the Investigator or Medical Monitor would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirement.
  • Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
  • Subject has a positive test for opioids.
  • Subject has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: All subjects
All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth)
Drug: OLZ/SAM
Olanzapine and Samidorphan fixed dose coated tablet taken once daily
Other Names:
  • ALKS 3831

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Up to 52 weeks
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alkermes, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David McDonnell, MD, Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALKS 3831-A313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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