Clinical trial for children and adolescents with schizophrenia or bipolar disorder
This research study aims to evaluate whether a new combination of medications could control metabolic effects, such as increased body mass, associated with the medication.
The available treatments for pediatric patients (girls, boys, and adolescents) diagnosed with or showing symptoms of Type I bipolar disorder or schizophrenia may, in some cases, cause metabolic effects such as weight gain or diabetes associated with the medication.
That is why this research study, also known as a clinical trial, is investigating whether a new combination of medications could help control the metabolic effects associated with the medication.
About the research study:
This clinical trial compares two treatments: OLZ/SAM (an investigational drug combination) versus olanzapine (the standard treatment, meaning the one commonly used for bipolar disorder and schizophrenia in pediatric patients).
The study lasts for 52 weeks, during which the disease symptoms will be evaluated, and changes in the participants' body mass index (BMI) will be measured.
Who can participate in this clinical trial
- Girls, boys, and adolescents between the ages of 10 and 17 who have symptoms consistent with Type I bipolar disorder (except in Argentina, where only patients aged 13 and older will be accepted).
- Adolescents between the ages of 13 and 17 who have symptoms consistent with schizophrenia.
To receive more information, simply fill out the form available on the button. Our team will contact you to provide further details about the study, answer your questions, and guide you through the application process to participate in this clinical trial.
It is important to know that:
- Participating in a clinical trial has no cost for the patient.
- To be contacted by the medical investigator, the patient must meet the main medical criteria described in the protocol.
- Filling out the form does not oblige you to participate, but we recommend doing so in order to receive more information.
- This is a clinical trial for children and adolescents, so the form must be completed by the patient’s parent or legal guardian.
This study is for people with
Requirements for the patient
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)
- 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 Screening
