Recruiting NCT05303064
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
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, Olanzapine.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Bipolar I Disorder. 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 →
Unsure about the terms? Read our patient guide →
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)
Overview
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Interventions
- 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
Primary outcome measures
- Change from baseline in body mass index (BMI) Zscore at week 12 [Time frame: 12 weeks]
Secondary outcome measures (7)
- Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12 [Time frame: 12 weeks]
- Time to all-cause discontinuation of study drug over 52 weeks [Time frame: Up to 52 weeks]
- Change from baseline in waist circumference [Time frame: 12 weeks]
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit [Time frame: 12 weeks]
- Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder [Time frame: 12 weeks]
- Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit [Time frame: 12 weeks]
- Incidence of Adverse Events [Time frame: Up to 52 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 26 centers
- Alkermes Investigator Site — Dothan
- Alkermes Investigator Site — Little Rock
- Alkermes Investigator Site — Encino
- Alkermes Investigator Site — Stanford
- Alkermes Investigator Site — Upland
- Alkermes Investigator Site — Colorado Springs
- Alkermes Investigator Site — Denver
- Alkermes Investigator Site — Hartford
- … and 18 more centers
Brazil · 6 centers
- Alkermes Investigator Site — Fortaleza
- Alkermes Investigator Site — Curitiba
- Alkermes Investigator Site — Goiânia
- Alkermes Investigator Site — Rio de Janeiro
- Alkermes Investigator Site — São Paulo
- Alkermes Investigator Site — São Paulo
Argentina · 5 centers
- Alkermes Investigator Site — La Plata
- Alkermes Investigator Site — La Plata
- Alkermes Investigator Site — Buenos Aires
- Alkermes Investigator Site — Córdoba
- Alkermes Investigator Site — Mendoza
Colombia · 5 centers
- Alkermes Investigator Site — Barranquilla
- Alkermes Investigator Site — Bello
- Alkermes Investigator Site — Bogotá
- Alkermes Investigator Site — Bogotá
- Alkermes Investigator Site — Pereira
Mexico · 5 centers
- Alkermes Investigator Site — Culiacán
- Alkermes Investigator Site — Estado de México
- Alkermes Investigator Site — León
- Alkermes Investigator Site — Monterrey
- Alkermes Investigator Site — Monterrey
Identifiers
NCT: NCT05303064 · ALKS 3831-A312