The available treatments for pediatric patients (girls, boys, and adolescents) diagnosed with or showing symptoms of bipolar disorder type I or schizophrenia may, in some cases, cause metabolic effects, such as weight gain, associated with medication.
Therefore, this research study, also known as a clinical trial, investigates whether a new combination of medications could have an effect on weight gain associated with medication.
In the clinical trial, two treatments are compared: olanzapine and samidorphan (a combination of investigational medications) versus olanzapine (the standard treatment, meaning the one commonly used for bipolar disorder and schizophrenia in pediatric patients).
The study lasts 52 weeks, during which the disease symptoms will be evaluated, and changes in the participants' body mass index (BMI) will be measured.
- Girls, boys, and adolescents between 10 and 17 years old with symptoms compatible with bipolar disorder type I (except in Argentina, which will only accept patients aged 13 and older).
- Adolescents between 13 and 17 years old with symptoms compatible with schizophrenia.
To receive more information, simply complete the form available on the button. Our team will contact you to provide more 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.
- Completing the form does not obligate you to participate, but we recommend doing so in order to receive more information.
- This is a clinical trial for children and adolescents; therefore, the form must be completed by the patient's mother, father, or legal guardian.