Bipolar I Disorder, Schizophrenia
Conditions
Keywords
Bipolar I Disorder, Schizophrenia, Samidorphan, Pediatric, Olzanzapine, Safety, LYBALVI
Brief summary
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
Interventions
DRUGOLZ/SAM
Olanzapine and Samidorphan fixed dose coated tablet taken once daily
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Up to 52 weeks |
Countries
Argentina, Brazil, Colombia, Mexico, United States
Contacts
STUDY_DIRECTORDavid McDonnell, MD
Alkermes, Inc.
Outcome results
None listed