Bipolar I DisorderPhase 3NCT04987229
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
A Phase 3 study testing OLZ/SAM in people with Bipolar I Disorder and Schizophrenia, run by Alkermes, Inc. at 35 sites in 5 countries.
Trial summary
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar I Disorder, Schizophrenia
- What is being tested?
- OLZ/SAM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 22 Oct 2021to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
35 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 5 countries
United States15 sites
Alkermes Investigational Site
Chicago, Illinois, 60611
Alkermes Investigational Site
Cincinnati, Ohio, 45229
Alkermes Investigational Site
Decatur, Georgia, 30030
Alkermes Investigational Site
Dothan, Alabama, 36303
Alkermes Investigational Site
Everett, Washington, 98201
Alkermes Investigational Site
Indianapolis, Indiana, 46202
Alkermes Investigational Site
Lincoln, Nebraska, 68526
Alkermes Investigational Site
Little Rock, Arkansas, 72204
Alkermes Investigational Site
Miami Lakes, Florida, 33016
Alkermes Investigator Site
New York, New York, 10016
Alkermes Investigational Site
Richmond, Virginia, 23220
Alkermes Investigational Site
Saint Charles, Missouri, 63304
Alkermes Investigational Site
Stanford, California, 94305
Alkermes Investigational Site
Washington D.C., District of Columbia, 20010
Alkermes Investigational Site
West Chester, Ohio, 45069
Brazil6 sites
Alkermes Investigational Site
Curitiba, Paraná, 80240-280
Alkermes Investigational Site
Fortaleza, Ceará, 60430-140
Alkermes Investigational Site
Goiânia, 74093-040
Alkermes Investigational Site
Rio de Janeiro, Rio de Janeiro, 22270-060
Alkermes Investigational Site
São Paulo, São Paulo, 05403-010
Alkermes Investigational Site
São Paulo, 01228-000
Argentina5 sites
Alkermes Investigational Site
Buenos Aires, Buenos Aires F.D., C1133AAH
Alkermes Investigational Site
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1181ACH
Alkermes Investigational Site
Córdoba, X5003DCE
Alkermes Investigational Site
La Plata, Buenos Aires, 1900
Alkermes Investigational Site
Mendoza, Mendoza Province, 5500
Mexico5 sites
Alkermes Investigational Site
Culiacán, Sinaloa, 80230
Alkermes Investigational Site
Gustavo A. Madero, State of Mexico, C.P. 07000
Alkermes Investigational Site
León, Guanajuato, 37000
Alkermes Investigational Site
Monterrey, Nuevo León, 64620
Alkermes Investigational Site
Monterrey, Nuevo León, 64710
Colombia4 sites
Alkermes Investigational Site
Barranquilla, 110121
Alkermes Investigational Site
Bello, 51053
Alkermes Investigational Site
Bogotá, 80020
Alkermes Investigational Site
Pereira, 660003
About this study
Official title: 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
- Conditions
- Bipolar I Disorder, Schizophrenia
- Being tested
- OLZ/SAM
- Keywords
- Bipolar I Disorder, Schizophrenia, Samidorphan, Pediatric, Olzanzapine, Safety, LYBALVI
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLZ/SAMDrug
Also called ALKS 3831
Olanzapine and Samidorphan fixed dose coated tablet taken once daily
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | 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) Receives: Drug: OLZ/SAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start22 Oct 2021
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David McDonnell, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987229
- Sponsor's protocol ID
- ALKS 3831-A313
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT04987229
- Acronym / sponsor ID
- ALKS 3831-A313
- Conditions
- Bipolar I Disorder, Schizophrenia
- Keywords
- Bipolar I Disorder, Schizophrenia, Samidorphan, Pediatric, Olzanzapine, Safety, LYBALVI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Drug: OLZ/SAMAll 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) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLZ/SAMAlso: ALKS 3831Olanzapine and Samidorphan fixed dose coated tablet taken once daily | Drug | All subjects |
Primary outcome
Incidence of adverse events
Time frame: Up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David McDonnell, MD study director
Alkermes, Inc.
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OLZ/SAM in people with Bipolar I Disorder and Schizophrenia, run by Alkermes, Inc. at 35 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Brazil, Argentina, Mexico, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.