Clinical trial NCT05303064: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Bipolar I Disorder
Keywords: LYBALVI
Schizophrenia
Bipolar I Disorder
Pediatric
Olanzapine
Samidorphan
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 220
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in body mass index (BMI) Zscore at week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12
timeFrame: 12 weeks
measure: Time to all-cause discontinuation of study drug over 52 weeks
timeFrame: Up to 52 weeks
measure: Change from baseline in waist circumference
timeFrame: 12 weeks
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit
timeFrame: 12 weeks
measure: Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder
timeFrame: 12 weeks
measure: Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit
timeFrame: 12 weeks
measure: Incidence of Adverse Events
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Alkermes Investigator Site
state: Alabama
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Encino
country: United States
facility: Alkermes Investigator Site
state: California
city: Stanford
country: United States
facility: Alkermes Investigator Site
state: California
city: Upland
country: United States
facility: Alkermes Investigator Site
state: California
city: Colorado Springs
country: United States
facility: Alkermes Investigator Site
state: Colorado
city: Hartford
country: United States
facility: Alkermes Investigator Site
state: Connecticut
city: Washington
country: United States
facility: Alkermes Investigator Site
state: District of Columbia
city: Miami Lakes
country: United States
facility: Alkermes Investigator Site
state: Florida
city: Miami
country: United States
facility: Alkermes Investigator Site
state: Florida
city: Decatur
country: United States
facility: Alkermes Investigator Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigator Site
state: Illinois
city: Indianapolis
country: United States
facility: Alkermes Investigator Site
state: Indiana
city: Saint Charles
country: United States
facility: Alkermes Investigator Site
state: Missouri
city: Lincoln
country: United States
facility: Alkermes Investigator Site
state: Nebraska
city: Omaha
country: United States
facility: Alkermes Investigator Site
state: Nebraska
city: Kinston
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Alkermes Investigator Site
state: Ohio
city: West Chester
country: United States
facility: Alkermes Investigator Site
state: Ohio
city: DeSoto
country: United States
facility: Alkermes Investigator Site
state: Texas
city: Fort Worth
country: United States
facility: Alkermes Investigator Site
state: Texas
city: Richmond
country: United States
facility: Alkermes Investigational Site
state: Virginia
city: Everett
country: United States
facility: Alkermes Investigator Site
state: Washington
city: La Plata
country: Argentina
facility: Alkermes Investigator Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Alkermes Investigator Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Alkermes Investigator Site
city: Córdoba
country: Argentina
facility: Alkermes Investigator Site
city: Mendoza
country: Argentina
facility: Alkermes Investigator Site
city: Fortaleza
country: Brazil
facility: Alkermes Investigator Site
state: Ceara
city: Curitiba
country: Brazil
facility: Alkermes Investigator Site
state: Parana
city: Goiânia
country: Brazil
facility: Alkermes Investigator Site
city: Rio De Janeiro
country: Brazil
facility: Alkermes Investigator Site
city: Sao Paulo
country: Brazil
facility: Alkermes Investigator Site
city: São Paulo
country: Brazil
facility: Alkermes Investigator Site
city: Barranquilla
country: Colombia
facility: Alkermes Investigator Site
city: Bello
country: Colombia
facility: Alkermes Investigator Site
city: Bogotá
country: Colombia
facility: Alkermes Investigator Site
city: Bogotá
country: Colombia
facility: Alkermes Investigator Site
city: Pereira
country: Colombia
facility: Alkermes Investigator Site
city: Culiacán
country: Mexico
facility: Alkermes Investigator Site
city: Estado De México
country: Mexico
facility: Alkermes Investigator Site
city: León
country: Mexico
facility: Alkermes Investigator Site
city: Monterrey
country: Mexico
facility: Alkermes Investigator Site
city: Monterrey
country: Mexico
facility: Alkermes Investigator Site
Study officials:
affiliation: Alkermes, Inc.
name: David McDonnell, MD
role: STUDY_DIRECTOR
References: