Enrolling by invitation NCT04987229

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Phase III Interventional Bipolar I Disorder Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: OLZ/SAM.
Who it may be relevant to: Registry conditions: Bipolar I Disorder, Schizophrenia. Basic parameters: 10 years — 17 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Colombia, Mexico
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Drug OLZ/SAM
Olanzapine and Samidorphan fixed dose coated tablet taken once daily

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 14 centers

Brazil · 6 centers

Argentina · 5 centers

Colombia · 5 centers

Mexico · 5 centers

NCT: NCT04987229 · ALKS 3831-A313