Frequently Asked Questions (FAQs)

What Is a Clinical Research Study?

Clinical research studies, also called clinical trials, look at an investigational drug or medical device to see if it is safe, how it works in the body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who are responsible for the study participants’ study-related care.

In most countries, the regulatory health authority, such as the Food and Drug Administration (FDA) in the United States, requires that several phases of clinical research be performed to better understand the safety and effectiveness of new investigational drugs and certain medical devices.

Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is a group that is responsible for helping to protect the rights and well-being of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.

Can My Child Leave the Study If They Change Their Mind?

Participation in any clinical research study is completely voluntary, and participants may choose to leave the study at any time for any reason. If your child would like to leave the study, you and your child should discuss this with your child’s study doctor, who will give you and your child information about how to do this safely.

What Should I Expect?

Before your child can take part in the ENLIGHTEN-Youth Study, they will first need to attend the screening visit(s) for initial tests and assessments to see if they are eligible to participate. After all necessary tests and assessments have been completed, and if they are eligible to participate, they may enter the study and may receive the investigational study drug or olanzapine.

How Long Will Study Participation Last?

Participation in the ENLIGHTEN-Youth Study lasts up to 60 weeks.