Would you or your child like to participate in a clinical research study for an investigational drug for children and teens with bipolar depression?

We are inviting you to take part in a study for children and teens, aged 10 to 17 years of age, who have been struggling with bipolar depression. The study team will be able to further discuss whether you or your child are eligible for the study. The purpose of this study is to evaluate the investigational drug for bipolar depression in children and teens.

The Balance Study is evaluating an investigational drug for children and teens with bipolar depression.

You or your child may be eligible to join the Balance Study if you or they:

  • Are 10 to 17 years old
  • Have a diagnosis of bipolar disorder
  • Are currently experiencing an episode of depression:
    • Symptoms of bipolar depression include depressed mood, loss of interest or pleasure, suicidal thoughts or behavior, difficulty falling asleep, loss of energy, difficulty concentrating

All study-related visits, tests, and investigational drug will be provided at no cost. In addition, compensation for time and travel may be provided. No health insurance is required.

All study-related care is provided by specialist physicians.
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What happens if I sign up? We will match you to a study location in your area that needs children and teens, aged 10 to 17, who are struggling with bipolar depression or notify you when one becomes available. The study team will then contact you and you may have the opportunity to participate, if qualified.


If you think you might like to participate in the Balance Study or would like more information, please enter your information below so we can see if you may qualify and can contact you about the study. Keep in mind that participation is entirely voluntary. If you do decide to take part in the Balance study, you may change your mind about participating at any time.

About Bipolar Depression

Bipolar disorder is a severe chronic mood disorder characterized by episodes of mania and depression.1 In the United States, in any given year, up to 4% of the population 18 years of age and older and 1.8% of children and teens are affected by this condition.

Bipolar disorder is characterized by at least one manic episode (a sustained period of an abnormally elevated mood, with intense energy or extreme and exaggerated behavior) that may be preceded or followed by a hypomanic or depressive episode (bipolar depression). Compared to manic and hypomanic episodes, bipolar depression is more common and usually lasts longer.

Although emotional and unruly behavior are a relatively normal part of childhood, there are a few signs and symptoms that may indicate a depressive episode associated with bipolar disorder (bipolar depression). Some may include:

  • Depressed mood
  • Loss of interest or pleasure
  • Suicidal thoughts or behavior
  • Difficulty falling asleep
  • Loss of energy
  • Difficulty concentrating2

Typically, mood stabilizers may be prescribed to help manage the ups and downs of bipolar depression in children and teens.

The Balance Study is evaluating an investigational drug for children and teens who have been struggling with symptoms of bipolar depression. The purpose of this study is to evaluate the investigational drug for bipolar depression in children and teens.

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Frequently Asked Questions

What is a research study?

A clinical research study (also called a clinical trial) helps to answer important questions about an investigational drug – these may include how well an investigational drug works for a certain condition. All medications must be tested in clinical research studies.

A clinical research study (or clinical trial) is the process by which new and innovative medications, interventions and treatments are approved and brought to market to help people live healthier lives. Even over-the-counter medications, such as aspirin that you may have used to counteract a headache, have gone through the clinical research study process before they were available at your local pharmacy.

The purpose of the Balance Study is to evaluate an investigational drug for children and teens who have been struggling with symptoms of bipolar depression.

The Balance Study will last for approximately 12 weeks. During your/your child’s participation in the study, you will visit a study center within a short distance of your home for various tests, assessments, and checkups.

Before participating in the study, participants will complete a screening period to see if they are eligible for the study. If they are eligible, participants will proceed to the 6-week treatment period where the investigational drug capsule or placebo will be taken by mouth at the same time daily. After the treatment period has been completed, there will be a follow-up period where the study staff will check in on your/your child’s well-being.

There is an approximately 50% chance that you or your child will be assigned to receive either the active investigational drug or placebo. In this study, the placebo is a medically inactive substance that looks the same as the active investigational drug but does not contain any active ingredient. Because of the type of study that you or your child is taking part in, neither you, your child, nor the study doctor or study staff will know whether your child is taking the active investigational drug or placebo during the study. However, this information is available should the study doctor decide it is medically necessary.

Participants who qualify to take part in the study may receive compensation for time and travel for all study-related visits. Please discuss this with the study team when they contact you.

There is no cost to participate in the Balance Study. If you decide to take part:

  • You will receive study-related care throughout the study from a team of experienced doctors and nurses
  • All study-related visits, tests, and investigational drug will be provided at no cost to you or your child.

The research team will be able to explain more about what the Balance Study will involve, and it is up to you or your child to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.

We match you to a study center within a close travel distance from your home. If the research study is not running in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information stored, you can opt out and we will delete your details.

About the Balance Study

The Balance Study is evaluating an investigational drug for children and teens who have been struggling with symptoms of bipolar depression. The purpose of this study is to evaluate the investigational drug for bipolar depression in children and teens.

The Balance Study will enroll about 380 children and teens with bipolar depression at participating study centers throughout North America and Europe.

Patients who take part in the study will visit a study center within a close distance to their home about 9 times over a period of approximately 12 weeks.

The study is divided into three (3) time periods: a screening/washout period, a treatment period, and a safety follow-up period. During each time period, you or your child will have one or more visits with the study doctor at the study center in your location. You may ask the study doctor or study staff how long each visit will last prior to the visit.

Who can take part in the Balance Study?

You or your child may be eligible to join the Balance Study if you or they:

  • Are 10 to 17 years old
  • Have a diagnosis of bipolar disorder
  • Are currently experiencing an episode of depression:
    • Symptoms of bipolar depression include depressed mood, loss of interest or pleasure, suicidal thoughts or behavior, difficulty falling asleep, loss of energy, difficulty concentrating

All study-related care is provided by specialist physicians.

There is no cost to participate in the study. Patients who take part will receive all study-related visits, tests, and investigational drug from a dedicated medical team at no cost.

Participants who qualify to take part in the study may receive compensation for time and travel for study-related visits.

The Balance Study is evaluating an investigational drug for children and teens who have been struggling with symptoms of bipolar depression.