Bipolar Disorder and Lithium Medicine Study

Part of the Collaborative Lithium Trials for Bipolar Disorders in Children

The Seattle Children’s Hospital Research Institute is conducting a research study to learn more about a medicine called lithium. Lithium is used to treat bipolar disorder in adults. Since there are very few studies about lithium use in children and teens, we want to find out more about how it works to treat children and teens with bipolar disorder.

Who can take part in the research study?

Families with children or teens ages 7 to 17 who have been diagnosed with bipolar disorder (or who are showing symptoms of bipolar disorder), have not participated in a lithium study and who are having manic episodes can take part in the study.

What is involved in the research study?

Children and teens who take part in the study will be asked to come to Children’s for up to 60 weeks (a little over a year) for study visits. We will prescribe lithium at one of three dose levels based on your child’s or teen’s weight. A doctor will talk with you about how your child or teen is doing during the visits. We will also check their weight, height, pulse and blood pressure. We’ll ask you to answer some written questions. We’ll also get a blood sample from your child or teen. In addition, we'll do an ECG to check how their heart is working during some study visits.

Parents interested in having their child or teen take part will be given a consent form that thoroughly explains all the details of the study, including the procedures, risks, benefits, compensation and more. 

What are the benefits of taking part in this research study?

If your child or teen takes part in this study, there may or may not be direct medical benefit to them. However, your child or teen will receive medical care, study medicine, careful monitoring and frequent visits with one of the leading psychiatrists for bipolar disorder. We’ll give you information about bipolar disorder and possible treatment options. This study may also help us learn to better care for other children and teens with bipolar disorder.

The biggest benefit is that your child or teen may be helping other children and teenagers. Clinical studies are needed to find new and improved treatments and diagnostic tools.

How much time will it take to take part in this research study? Will we be paid for our time?

Study participants will be asked to come to Children’s for up to 60 weeks (a little over a year) for study visits. Most of the visits will last about one hour. A couple of the visits will last up to four hours. Children and teens will receive $25 for regular visits and $50 for the longer visits.

What happens after the research study is over?

Whether your child or teen completes the study or quits before it’s over, the child psychiatrist will work closely with your family to arrange for ongoing treatment. The referrals will likely not be with members of the study research team or for providers in the Children’s system. Your family would have to pay for ongoing treatment.

Why is this research study important?

Although bipolar disorder is rare, there has been a recent increase in how often children and teens are diagnosed with the disorder. We still have much to learn about the treatment of this disorder. There is a lack of clinical information about lithium treatment in children and teens.

This study, which is part of a national study called the Collaborative Lithium Trials (CoLT), will help provide new data about how lithium works to treat bipolar disorder in children and teenagers. The results of this nationwide study will provide the most complete information about lithium treatment in children and teens to date.

Who is funding this research study?

The National Institutes of Health (NIH) is funding this research study.

Where does the research study take place?

The study is taking place at the Pediatric Clinical Research Center at Children’s Hospital and Regional Medical Center in Seattle, Wash.

How many children and teens will take part in this research study?

A total of 60 children and teens from seven research sites across the United States will take part in this research study.

Who can I contact for more information about this study?

For more information, please contact Christopher Budech, clinical research assistant, at (206) 987-3399. Jon McClellan, MD, is the principal investigator for Children’s research team.