Phase 3 Bipolar Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Young people aged 13 to 17 who have been diagnosed with schizophrenia, or aged 10 to 17 who have been diagnosed with bipolar I disorder, based on standard diagnostic guidelines (DSM-5)
• People who are already receiving care as an outpatient, or who the trial doctor believes will be able to receive outpatient care by the second week of the study
• People who have a reliable family member or legal guardian available to support their care outside of a hospital setting
• People who are currently taking olanzapine, or who are taking a different antipsychotic medication that has not worked well enough — for example, due to unsatisfactory results, side effects, or difficulty sticking to the medication — based on the trial doctor's judgment
• People who the trial doctor considers to be no danger to themselves or others

Who may not be able to join:

• People currently experiencing a major depressive episode (in bipolar I disorder), or who have another mental health diagnosis such as schizoaffective disorder, untreated or unstable major depressive disorder, or any other psychiatric condition that could interfere with taking part in the study
• People with a history of seizure disorder (except childhood febrile seizures), a serious head injury with loss of consciousness in the 12 months before screening, or another significant neurological condition in the 12 months before screening
• People currently considered to be at risk of suicide, as assessed by the trial doctor or through a standard suicide risk assessment tool
• People who have taken olanzapine for 14 days or more in the month before screening, or who have previously had a poor or inadequate response to olanzapine
• People who have taken opioid pain medications within 14 days before screening (or within 30 days for long-acting opioid medications)
• People who expect to need opioid pain medication during the study period — for example, due to a planned surgery
• People who have taken opioid-blocking medications, such as naltrexone or naloxone (in any form), within 60 days before screening
• People who have received a long-acting injectable antipsychotic medication within 3 injection cycles before screening
• People whose BMI falls above the 98th percentile or below the 5th percentile for their age (confirm with trial site)
• People who have been diagnosed with diabetes, or whose blood sugar results at screening indicate prediabetes (HbA1c of 6% or higher)
• People who have started a smoking cessation program in the 6 months before screening, or who have joined a weight management program or made significant changes to their diet or exercise habits within 6 weeks before screening
• People who have taken part in a clinical trial of an investigational product within the 30 days before screening

Important: Always verify eligibility with the trial site directly before applying.