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Enrolling by invitationPhase 3

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.

Key facts

Who runs it
Alkermes, Inc.
Where
Buenos Aires, Ciudad Autonoma de Buenos Aire, Córdoba, La Plata, and Mendoza, ArgentinaSee the 5 sitesAlso in 4 other countries, 28 sites
Trial code
Registry title
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Status
Enrolling by invitation
Phase
Phase 3
People taking part
236 people, planned
Started
22 Oct 2021
Expected to end
Sept 2027
Type of study
Interventional
Treatments tested
  • OLZ/SAM
Record updated
14 August 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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 take part

  • 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

Check if you might fit

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?

Where in Argentina

Also in 4 other countries, 28 sites

  • Buenos Aires, Buenos Aires F.D.Hospital not named in the registryNo longer taking part
  • Ciudad Autonoma de Buenos Aire, Buenos AiresHospital not named in the registryNo longer taking part
  • CórdobaHospital not named in the registryNo longer taking part
  • La Plata, Buenos AiresHospital not named in the registryNo longer taking part
  • Mendoza, Mendoza ProvinceHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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

The group in the trial

  • All subjectsTreatment being tested

    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)

    Treatment: OLZ/SAM

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Plain-language title
Long-term safety of OLZ/SAM in young people with schizophrenia or bipolar I disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04987229, who can take part
Record updated
14 August 2026