Long-term safety of OLZ/SAM in young people with schizophrenia or bipolar I disorder
Tests long-term safety of OLZ/SAM in young people with schizophrenia or bipolar I.
Plain-language title generated from the registry record
Registry title: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Key facts
- Where
- Culiacán, Gustavo A. Madero, León, and Monterrey, MexicoSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with schizophrenia or bipolar I disorder who finished an earlier OLZ/SAM study and may gain from continuing the treatment.
- Age
- 10 to 17 years
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia or bipolar I disorder, in people who finished study ALKS 3831-A311 or ALKS 3831-A312.
- Earlier treatment
- Must have finished the treatment period of study ALKS 3831-A311 or ALKS 3831-A312 within 10 days before joining, or left ALKS 3831-A312 early because of clinically significant weight gain.
Main reasons for not taking part
- Current suicide risk, as judged by the investigator
- Taking medicines that cannot be combined with olanzapine
- Positive test for opioids
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed
- Any finding that the investigator thinks would put safety at risk or prevent following the visit schedule
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT04987229, who can take part
Where in Mexico
- CuliacánCuliacán, MexicoNo longer taking part
- Gustavo A. MaderoGustavo A. Madero, MexicoNo longer taking part
- LeónLeón, MexicoNo longer taking part
- MonterreyMonterrey, MexicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alkermes, Inc.
- Trial code
- NCT04987229
- Record updated
- 14 August 2026
- Original description
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorderRead full original descriptionShow less
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
Inclusion: 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: Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine; 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; 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 has a positive test for opioids.