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

Enrolling by invitation · Phase 3

Conditions studied: Bipolar I Disorder, Schizophrenia

In brief

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

Key facts

Study ID

NCT04987229

Run by

Alkermes, Inc.

People needed

236

Starts

2021-10-22

Expected to finish

2027-09-01

Last updated by the study team

2026-06-02

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alkermes Investigational Site — Dothan, Alabama, United States
• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Stanford, California, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Miami Lakes, Florida, United States
• Alkermes Investigational Site — Decatur, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Indianapolis, Indiana, United States
• Alkermes Investigational Site — Saint Charles, Missouri, United States
• Alkermes Investigational Site — Lincoln, Nebraska, United States
• Alkermes Investigational Site — Cincinnati, Ohio, United States
• Alkermes Investigational Site — West Chester, Ohio, United States
• Alkermes Investigational Site — Richmond, Virginia, United States
• Alkermes Investigational Site — Everett, Washington, United States
• Alkermes Investigational Site — Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
• Alkermes Investigational Site — La Plata, Buenos Aires, Argentina
• Alkermes Investigational Site — Buenos Aires, Buenos Aires F.D., Argentina
• Alkermes Investigational Site — Mendoza, Mendoza Province, Argentina
• Alkermes Investigational Site — Córdoba, Argentina
• Alkermes Investigational Site — Fortaleza, Ceará, Brazil
• Alkermes Investigational Site — Curitiba, Paraná, Brazil
• Alkermes Investigational Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Alkermes Investigational Site — São Paulo, São Paulo, Brazil
• Alkermes Investigational Site — Goiânia, Brazil
• Alkermes Investigational Site — São Paulo, Brazil

Full record on ClinicalTrials.gov

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