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
- Curitiba, Fortaleza, Goiânia, Rio de Janeiro, and São Paulo, BrazilSee the 5 sites
- Phase
- Phase 3
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 Brazil
- CuritibaCuritiba, BrazilNo longer taking part
- FortalezaFortaleza, BrazilNo longer taking part
- GoiâniaGoiânia, BrazilNo longer taking part
- Rio de JaneiroRio de Janeiro, BrazilNo longer taking part
- São PauloSão Paulo, BrazilNo 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.