To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Elegibilidad

Edad mínima: 10 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2
Subject has reliable family/legal guardian support available for outpatient management
Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment
Subject must not be a danger to self or others (per Investigator judgement)

Criterios de exclusión

Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study
Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening
Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)
Subject has received olanzapine for \>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine
Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)
Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)
Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening
Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening
Subject has a BMI percentile \>98th or \<5th
Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \[HbA1c\] \>= 6%)
Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening
Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening

Intervenciones

drug

OLZ/SAM

OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.

drug

Olanzapine

The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day

Ubicaciones

Alkermes Investigator Site

La Plata, Buenos Aires, Argentina

RECRUITING

Alkermes Investigator Site

La Plata, Buenos Aires, Argentina

RECRUITING

Alkermes Investigator Site

Buenos Aires, Argentina

RECRUITING

Alkermes Investigator Site

Córdoba, Argentina

RECRUITING

Alkermes Investigator Site

Mendoza, Argentina

RECRUITING

A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

OLZ/SAM

Olanzapine

Ubicaciones

Alkermes Investigator Site

Alkermes Investigator Site

Alkermes Investigator Site

Alkermes Investigator Site

Alkermes Investigator Site

Patrocinadores

Contactos

Global Clinical Services

Global Clinical Services