teen-bipolar – Advanced Discovery Research

A research study for teenagers with bipolar depression

Caring for someone with a mental health condition can be a challenge, as finding the right treatment approach often takes time. By being in this study, your child will help researchers understand more about a potential new medication, referred to as the “study drug."  The study drug is being looked at for major depressive episodes (MDEs) in children and teenagers with bipolar disorder, also known as bipolar depression. The study drug is called “lumateperone.”

Why is this study important?

Currently available medications for children experiencing MDEs linked to bipolar disorder may increase the risk of self-harm. These medications may also have side effects, such as weight gain, high blood pressure, diabetes, and high cholesterol.

The 421 Pediatric Bipolar Study will look at how safe the study drug is and how well it works in children and teenagers with bipolar depression. The study also aims to find out if the study drug helps to reduce the severity of their depression.

What is the purpose of this study?

The United States Food and Drug Administration (FDA) has approved lumateperone (called CAPLYTA®) for the treatment of bipolar depression in adults. However, lumateperone is not approved for the treatment of children and teenagers with bipolar depression. The 421 Pediatric Bipolar Study will look at how safe the study drug is and how well it works in children and teenagers with bipolar depression. The study also aims to find out if the study drug helps to reduce the severity of their depression.

Who can participate in this study?

This study is enrolling participants who are:


  • 13–17 years of age with a diagnosis of bipolar I or II disorder
  • Currently experiencing depression without psychosis that lasts between 1 and 12 months.

This is not a complete list of study requirements. The study doctor will review the full study requirements with you.

Study open to adolescents 13-17 years of age

How long will this study last?
Participants will be in this study for about 2 months and will have up to 9 visits to the study site during that time.

What can participants in this study expect?
In the 421 Pediatric Bipolar Study, there will be four study periods. First, there is a screening period, which will last up to 14 days. During the screening period, doctors will decide if individuals are eligible to participate in the study.

Next is the baseline visit. You and your child will visit the study center for some tests and assessments. Your child will receive their first dose of the study drug/placebo under the supervision of the study team. The study team will give you enough study drug/placebo doses to last until your child’s next visit. A placebo is a substance that looks like the study drug but has no study drug in it. Participants will be chosen at random (by chance, like flipping a coin) to receive the study drug or the placebo.

After the baseline visit, your child will enter the study treatment period. During this time your child will:

  • visit the study center with you every week for 6 weeks for their tests and assessments
  • continue to take the study drug/placebo at home
  • take 1 capsule of the study drug/placebo by mouth every day in the evening, with or without food, under your supervision.
  • At each visit, the study team will give you enough study drug/placebo doses to last until your child’s next visit.
  • At the end of the study treatment period, your child may be invited to take part in a long-term safety study where all participants will receive lumateperone. The study doctor will let you know if this applies to your child and discuss it with you in detail.

If your child does not participate in the long-term safety study, you and your child will have 1 last visit to the study center. This visit will be about 1 week after the last dose of the study drug/placebo.  At this visit, the study doctor or study team member will do some assessments and ask questions about:

  • your child’s health and how they are feeling
  • any medications or supplements they have taken

Lab tests, physical exams, and other assessments and questionnaires will be conducted as part of this study.

What are the costs to take part in this study?
You do not have to pay for the study drug, supplies, or tests that are part of the clinical study. What risks are involved for study participants? There are possible risks involved with any clinical study. The research doctor will review the risks with you, and you will be closely monitored by the research staff throughout the study.

Participants will receive a stipend of $127.00 per visit.  Advanced Discovery Research can provide transportation to and from the site, or you can be reimbursed up to $57.00 per visit if you provide your own transportation.

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