Last updated 26 days ago
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
220 patients around the world
Available in Argentina, Mexico, United States, Colombia, Brazil
Alkermes, Inc.
21Research sites
220Patients around the world
This study is for people with
Schizophrenia
Bipolar disorder
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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) criteriaSubject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2Subject has reliable family/legal guardian support available for outpatient managementSubject 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 judgmentSubject must not be a danger to self or others (per Investigator judgement)Additional eligibility criteria apply.
- 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 studySubject 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 ScreeningSubject 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 olanzapineSubject 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 ScreeningSubject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to ScreeningSubject has a BMI percentile >98th or <5thSubject 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 ScreeningSubject has participated in a clinical study of an investigational product within the last 30 days prior to ScreeningAdditional eligibility criteria apply.
Sites
Instituto Médico Damic S.R.L.
Recruiting
Resolution Psychopharmacology Research Institute
Recruiting
Instituto de Neurociencias San Agustín - INSA
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
Recruiting
Instituto Goiano de Neuropisquiatria
Recruiting
CPQuali Pesquisa Clínica
Recruiting
IPq-HCFMUSP - Instituto de Psiquiatria do Hospital das Clínicas da FMUSP
Recruiting
Ruschel Medicina e Pesquisa Clínica
Recruiting
Hospital Universitário Walter Cantídio - Universidade Federal do Ceará - Fortaleza, Ceara
Recruiting
StudyENLIGHTEN-Youth
SponsorAlkermes, Inc.
Study typeInterventional
Conditions
SchizophreniaBipolar disorder
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05303064
