About the ENLIGHTEN-Youth Study

The ENLIGHTEN-Youth Study is evaluating how an investigational study drug may work in children and adolescents with schizophrenia or bipolar I disorder.

Who May Qualify

Eligible participants must meet the following criteria:

  • Male or female aged 10–17 years
    • 13–17 years with schizophrenia
      or
    • 10–17 years with bipolar I disorder
  • Previously or currently receiving treatment with an antipsychotic medicine
  • Be able to attend the scheduled site visits; follow the treatment plan, study rules, and guidelines on contraception; and undergo laboratory tests and other study procedures

There are additional eligibility requirements that the study doctor will explain to you.

Study Participation

Participation in the ENLIGHTEN-Youth Study lasts up to 60 weeks (a little over a year) and consists of three periods:

Screening

This period lasts up to 30 days, and the purpose is to make sure the study is a good match for your child.

Investigational Treatment

This period lasts 52 weeks. Your child will receive either the study drug or olanzapine, and the study team will monitor your child’s health while they are taking the assigned study drug. Participants will return for visits every other week until Week 12, followed by monthly visits until Week 52.

Follow-Up

This period lasts four weeks, and the purpose is to check on your child’s health after they have stopped taking the assigned study drug.

Throughout the study, the study doctor may perform a number of tests and procedures, including but not limited to:

  • Recording your child’s medical history
  • Conducting physical exams
  • Measuring your child’s vital signs
  • Conducting pregnancy tests (if applicable)
  • Collecting blood and urine samples

About the Study Drug

The investigational study drug in the ENLIGHTEN-Youth Study is the combination of olanzapine and samidorphan (OLZ/SAM). OLZ/SAM is administered as an oral tablet taken once daily. In this study, the investigational study drug is being compared to olanzapine.

See if your child may qualify