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Children: Bipolar Disorder

Join a Research Study: Bipolar Disorder

A Study of Brain Function and Symptoms in Children who have Bipolar Disorder, or a Parent or Sibling with Bipolar Disorder

This research protocol seeks to learn more about bipolar disorder in children and adolescents ages 6-17. The protocol studies children who have been diagnosed with bipolar disorder, and those who have a sibling or parent with bipolar disorder and are thus considered “at risk” for developing the disorder. Researchers study the moods and behaviors of children with bipolar disorder and those at risk for the disorder, and use specialized testing and brain imaging to learn about brain changes associated with the disorder. This is a descriptive, longitudinal study.

Study Procedures

After a preliminary phone interview, participants may be invited to NIMH for an on-site evaluation to determine eligibility. If eligibility criteria are met, participants may choose to enroll in the descriptive study. Study procedures include interviews, research testing, and brain imaging scans. Testing and brain imaging occurs at yearly visits, which can continue to age 25. Yearly phone contact occurs in between visits.

Children with bipolar disorder must be in treatment with a psychiatrist or provider, and/or medically healthy and not currently hospitalized, psychotic or suicidal.

The studies are conducted at the NIH Clinical Center in Bethesda, Maryland and enroll participants from across the USA.  All clinical evaluations, research procedures and outpatient visits are free of cost. Travel expenses and lodging are paid by NIMH. Both parent and child must agree to the child’s participation in research. Children and parents are compensated for participation.

To find out about study criteria and qualifications, or for more information, please call (301 496-8381) or email us at bipolarkids@mail.nih.gov

A) Descriptive/longitudinal study for children with bipolar disorder:  When children have bipolar disorder, do their brains work in ways that are different than those of other children? How do the symptoms of bipolar disorder change as children grow up?

This research study will describe the moods, behaviors and brain development of bipolar disorder in children over time.  Participants, ages 6-17, may be invited to enroll after an initial outpatient visit. If found to be eligible based on their past mood and behaviors, they are invited to participate in the study.  Face-to-face evaluations and study procedures occur at yearly study visits, which can continue to age 25. Yearly phone contact occurs between visits.

Yearly study visits last one to two days and may include obtaining information about mood and behavior, research tasks, and Magnetic Resonance Imaging (MRI). Research tasks include questionnaires, interviews, and direct observation; tests of mood, memory, and thinking using paper-and-pencil and computer tests; behavioral research tasks; and Magnetic Resonance Imaging (MRI) scans.  Children continue in treatment with a psychiatrist or other provider in their community and continue taking the medications prescribed by that clinician. This study does not involve special treatment medications.

B) Descriptive/longitudinal study for children “at risk” for bipolar disorder:

Most children with a parent or sibling with bipolar disorder do not themselves develop bipolar disorder.  However, they are at increased risk to do so compared to children who do not have a relative with the illness.  The purpose of this study is to compare symptoms and brain function in children “at risk” for bipolar disorder vs. children who are not at risk, with the ultimate goal of being able to predict who will develop the illness and how to prevent it.

In this study, children, ages 6-17 who have a parent or a sibling with bipolar disorder participate in non-treatment research. Children may or may not have been diagnosed with a psychiatric disorder.  Those taking medications for Attention Deficit Hyperactivity Disorder may be eligible for participation. This study does not involve treatment. 

Eligibility is based on confirming that the child’s parent or sibling has a diagnosis of bipolar disorder, and on the at-risk child’s own past mood and behaviors. Interested families complete a preliminary telephone interview. Those who appear to be eligible come to NIMH for an initial outpatient visit at which the child receives a clinical assessment and testing. If eligible, the child and his/her family are invited to participate in the descriptive longitudinal study for children “at risk” for bipolar disorder.  Study procedures like those described in for the descriptive longitudinal study for children with bipolar disorder (see A, above).  

To find out if you qualify, email NIMH or call 1-301-496-8381 [TTY: 1-866-411-1010].

Join a Research Study: Bipolar Disorder

A Study of Brain Function and Symptoms in Children with Severe Mood Dysregulation

This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD) display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Researchers will describe the moods and behaviors of children with these symptoms and use specialized testing and brain imaging to learn about the brain changes associated with this disorder. 

Study participation begins with an initial outpatient evaluation that lasts one day. Then, testing and brain imaging are completed at two-three day outpatient visits which occur every two years until participants reach age 25. Phone contact occurs every six months in between visits.

Descriptive/Longitudinal Study: When children have severe mood dysregulation (SMD), do their brains work differently than those of other children? How do their symptoms change as the children grow up?

After a preliminary phone interview, participants may be invited to NIMH for an on-site assessment. Children must be in treatment with a psychiatrist or provider, and/or medically healthy and not currently hospitalized, psychotic or suicidal.

A principal focus of the research is how mood, behavior, and brain development of children with severe mood dysregulation (SMD) change over time. Study procedures at the two-three day visits may include questionnaires and interviews; paper-and-pencil and computer tests of mood, memory, and thinking; specialized computer games; and structural and functional Magnetic Resonance Imaging (MRI) scans. These visits occur every two years until age 25. Children continue in treatment with a provider or psychiatrist in their community. This study does not involve treatment medications.

To find out if you qualify, email NIMH or call 1-301-496-8381 [TTY: 1-866-411-1010].

Join a Research Study: Bipolar Disorder

Clinical Trial of Citalopram and Methylphenidate in Severe Mood Dysregulation

This study is testing the effectiveness of methylphenidate plus citalopram vs. methylphenidate plus placebo for decreasing irritability in children with severe mood dysregulation (SMD). Children with SMD display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums).

Children ages seven to 17 with SMD may be eligible to participate in this 12- to 15-week inpatient or outpatient study. This study has four phases. During Phase I participants are gradually withdrawn from all current psychotropic medications. Phase II is a one-week psychotropic medication-free period. During Phase III, which lasts two weeks, participants are treated with methylphenidate alone. Phase IV lasts for eight weeks. During this time, participants continue methylphenidate treatment and are randomly assigned to also receive either citalopram or placebo.

At the end of the study, those who received methylphenidate plus placebo will have the opportunity to receive methylphenidate plus active citalopram if clinically appropriate.

All procedures and medications associated with the research are provided at no cost to participants, and transportation expenses are reimbursed by NIMH. Schooling will be provided while on the inpatient unit or in day treatment.

To find out if you qualify, email NIMH or call 1-301-496-8381 [TTY: 1-866-411-1010].