Bipolar 1 DisorderNCT07744113
An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)
A study testing OLZ/SAM in people with Bipolar 1 Disorder and Schizophrenia Disorder, run by Alkermes, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar 1 Disorder, Schizophrenia Disorder
- What is being tested?
- OLZ/SAM
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Child
Who may be able to join
- The Participant has completed 52-weeks on the ALKS 3831-A313 clinical study.
- The Participant must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient.
- The Participant will benefit from continued therapy with OLZ/SAM per the clinical judgment of the Participant's Physician.
- The Participant can be treated on an outpatient basis.
- The Participant agrees to abide by the contraception requirements specified in the protocol for the duration of the study.
- The Participant's parent(s)/legal guardian(s) is/are considered reliable by the Physician and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
Who cannot join
- The participant is eligible for commercial OLZ/SAM (LYBALVI®) through standard commercial pathways (≥18) for approved use.
- The participant is at a current risk of suicidal behavior as assessed by the Participant's Physician or answered "Yes" to questions 4 or 5 on the C-SSRS and/or had a suicide attempt within the past 12 months.
- The participant has any finding that in the view of the Physician would compromise the safety of the Participant or affect their ability to fulfill the Program requirements.
- The participant is currently taking medications that are contraindicated with olanzapine or OLZ/SAM use or exhibit drug interaction potential with olanzapine or OLZ/SAM (such as the Participant is currently using opioids or undergoing acute opioid withdrawal).
- The participant has a positive test for opioids.
- The participant is currently enrolled in an interventional clinical study or Early (or Expanded) Access Program (other than the OLZ/SAM Program) or used any investigational drug or device (other than the OLZ/SAM) within 30 days prior to starting the Program.
- The participant has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the Program and for 90 days after any treatment with OLZ/SAM.
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Alkermes Investigator Site
Miami, Florida, 33126
About this study
Official title: An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder
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
- Being tested
- OLZ/SAM
- Keywords
- Olanzapine, Pediatric, LYBALVI, Samidorphin
- 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 LYBALVI, ALKS 3831, olanzapine/samidorphan
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 1 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744113
- Sponsor's protocol ID
- ALKS 3831-315
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT07744113
- Acronym / sponsor ID
- ALKS 3831-315
- Conditions
- Bipolar 1 Disorder, Schizophrenia Disorder
- Keywords
- Olanzapine, Pediatric, LYBALVI, Samidorphin
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- First posted
- 4 Aug 2026 (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 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.
Study design
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (6 listed)
- The Participant has completed 52-weeks on the ALKS 3831-A313 clinical study.
- The Participant must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient.
- The Participant will benefit from continued therapy with OLZ/SAM per the clinical judgment of the Participant's Physician.
- The Participant can be treated on an outpatient basis.
- The Participant agrees to abide by the contraception requirements specified in the protocol for the duration of the study.
Key exclusion criteria (7 listed)
- The participant is eligible for commercial OLZ/SAM (LYBALVI®) through standard commercial pathways (≥18) for approved use.
- The participant is at a current risk of suicidal behavior as assessed by the Participant's Physician or answered "Yes" to questions 4 or 5 on the C-SSRS and/or had a suicide attempt within the past 12 months.
- The participant has any finding that in the view of the Physician would compromise the safety of the Participant or affect their ability to fulfill the Program requirements.
- The participant is currently taking medications that are contraindicated with olanzapine or OLZ/SAM use or exhibit drug interaction potential with olanzapine or OLZ/SAM (such as the Participant is currently using opioids or undergoing acute opioid withdrawal).
- The participant has a positive test for opioids.
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: LYBALVI, ALKS 3831, olanzapine/samidorphanOLZ/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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- ALKS 3831-A313Link provided by the sponsor.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OLZ/SAM in people with Bipolar 1 Disorder and Schizophrenia Disorder, run by Alkermes, Inc. at 1 site in United States.
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 7 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: status not confirmed, as of the sponsor's last update on 4 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 1 site in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senior Director Global Clinical Services (888-235-8008 (US Only), clinicaltrials@alkermes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 4 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.