Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Recruiting · NCT05303064 · Interventional (participants receive a specific treatment) · Lead sponsor: Alkermes, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
OLZ/SAMOlanzapine
What this trial is about
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Who can take part
Age range
10 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
47 locations listed across 19 US states.
- Alkermes Investigator Site - Dothan, Alabama, United States
- Alkermes Investigator Site - Little Rock, Arkansas, United States
- Alkermes Investigator Site - Encino, California, United States
- Alkermes Investigator Site - Stanford, California, United States
- Alkermes Investigator Site - Upland, California, United States
- Alkermes Investigator Site - Colorado Springs, Colorado, United States
- Alkermes Investigator Site - Denver, Colorado, United States
- Alkermes Investigator Site - Hartford, Connecticut, United States
- Alkermes Investigator Site - Washington D.C., District of Columbia, United States
- Alkermes Investigator Site - Miami, Florida, United States
- Alkermes Investigator Site - Miami Lakes, Florida, United States
- Alkermes Investigator Site - Decatur, Georgia, United States
- Alkermes Investigator Site - Chicago, Illinois, United States
- Alkermes Investigator Site - Indianapolis, Indiana, United States
- Alkermes Investigator Site - Saint Charles, Missouri, United States
- Alkermes Investigator Site - Lincoln, Nebraska, United States
- Alkermes Investigator Site - Omaha, Nebraska, United States
- Alkermes Investigator Site - Paramus, New Jersey, United States
- Alkermes Investigator Site - New York, New York, United States
- Alkermes Investigational Site - Kinston, North Carolina, United States
- Alkermes Investigator Site - Cincinnati, Ohio, United States
- Alkermes Investigator Site - West Chester, Ohio, United States
- Alkermes Investigator Site - DeSoto, Texas, United States
- Alkermes Investigator Site - Fort Worth, Texas, United States
- Alkermes Investigational Site - Richmond, Virginia, United States
- Alkermes Investigator Site - Everett, Washington, United States
- Alkermes Investigator Site - Barranquilla, Colombia
- Alkermes Investigator Site - Bello, Colombia
- Alkermes Investigator Site - Bogotá, Colombia
- Alkermes Investigator Site - Bogotá, Colombia
- Alkermes Investigator Site - Buenos Aires, Argentina
- Alkermes Investigator Site - Culiacán, Mexico
- Alkermes Investigator Site - Córdoba, Argentina
- Alkermes Investigator Site - Estado de México, Mexico
- Alkermes Investigator Site - Goiânia, Brazil
- Alkermes Investigator Site - León, Mexico
- Alkermes Investigator Site - Mendoza, Argentina
- Alkermes Investigator Site - Monterrey, Mexico
- Alkermes Investigator Site - Monterrey, Mexico
- Alkermes Investigator Site - Pereira, Colombia
- Alkermes Investigator Site - Rio de Janeiro, Brazil
- Alkermes Investigator Site - São Paulo, Brazil
- Alkermes Investigator Site - São Paulo, Brazil
- Alkermes Investigator Site - La Plata, Buenos Aires, Argentina
- Alkermes Investigator Site - La Plata, Buenos Aires, Argentina
- Alkermes Investigator Site - Fortaleza, Ceará, Brazil
- Alkermes Investigator Site - Curitiba, Paraná, Brazil