Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
Condition: Bipolar Disorder; Mood Disorders; Attention Deficit Hyerpactivity Disorder
MeSH terms: Bipolar Disorder; Mood Disorders
Study type: Observational

Summary: 
      This research protocol seeks to learn more about bipolar disorder in children and adolescents
      ages 6-17. Researchers will describe the moods and behaviors of children with bipolar
      disorder and use specialized testing and brain imaging to learn about specific brain changes
      associated with the disorder. This 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.
    

Detailed description: 
      Objective:

      For this protocol we define Bipolar Spectrum disorders (BSD) as the propensity to have a
      manic episode by having Bipolar Disorder or Substance/Medication-Induced Bipolar and Related
      Disorder. BSD in children and adolescents is receiving increased research attention, but
      important questions remain about its developmental trajectory, phenomenology and behavioral
      correlates, and little is known about its underlying neural mechanisms. In its study of youth
      with BSD, this study has three objectives:

        1. to use longitudinal techniques to characterize the clinical and physiological
           manifestations of pediatric BSD, and to use cross-sectional techniques (e.g., comparing
           children and adults with BSD on these measures) to provide preliminary data to guide
           such longitudinal studies

        2. to identify and follow longitudinally behavioral, neuropsychological,
           neurophysiological, and neuroanatomical correlates of pediatric BSD, and compare to
           children with chronic irritability and hyperarousal symptoms (severe mood dysregulation,
           SMD, as outlined in protocol 02-M-0021), youth with attention deficit hyperactivity
           disorder (ADHD), and typically developing youth.

        3. to examine genetic and familial correlates of pediatric BSD

      Study population:

      There are 11 separate populations being studied in this protocol:

        1. Children and adolescents between the ages of 6-17 years old who meet criteria for BSD.

        2. Adults between the ages of 18-58 years old who meet criteria for BD, including those age
           18-25 with BSD.

        3. Control populations of: a) Healthy volunteer children and adolescents between the ages
           of 3-17 years old, b) Parents of healthy volunteer children or healthy adults in
           research, c) Children 8-17 years old with attention deficit hyperactivity disorder
           (ADHD), who do not have a mood disorder.

        4. First and second-degree biological relatives of those in (B.1) or (B.2), above, and are
           between 3-58 years old.

        5. A subgroup of these cohorts will be Old Order Amish individuals who fulfill eligibility
           for (1), (2), (3a), (3b), or (4).

      Design:

      For children and adolescents with BSD (i.e. Bipolar Disorder or those with
      Substance/Medication-Induced Bipolar and Related Disorder), this study is an outpatient
      characterization and longitudinal follow-along design. Once determined to be eligible,
      individuals come for an initial assessment, and then at varying intervals they return for
      clinical interviews, behavioral tasks, and structural and functional MRI.

      For children and adolescents who are relatives of individuals with BSD, this is an outpatient
      follow-along design during which individuals come for an outpatient assessment and at 2-year
      intervals for clinical interviews, behavioral tasks, and structural and functional MRI.

      For healthy volunteer children, children with only ADHD, adults with BD, and parents of
      healthy volunteer children, this study is an outpatient cross-sectional study that includes
      clinical interviews, behavioral tasks, and structural and functional MRI.

      For all others, individuals come to NIH for clinical interviews, behavioral tasks, and MRI.

      For most individuals in the Amish community, the investigation occurs in the field, where
      they receive clinical interviews and behavioral tasks. Some may choose to come to the NIH to
      participate in behavioral testing and MRI.

      For all individuals, genetic material from saliva or blood is obtained under protocol
      01-M-0254.

      Outcome measures:

      This study will examine between group differences in clinical, behavioral, genetic,
      neuroanatomical, and neurophysiological variables in individuals with BSD, their relatives,
      and healthy volunteers. Findings in children with BSD will also be compared to those with
      severe mood dysregulation, sometimes called a broad phenotype of pediatric BD, recruited
      under protocol 02-M-0021 (Nottelman, 2001).

      Longitudinal clinical, behavioral, and neuroanatomical data will also be obtained.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        There are 11 separate populations being studied in this protocol: 1. Children and
        adolescents between the ages of 6-17 years old who meet criteria for BSD. 2. Adults between
        the ages of 18-58 years old who meet criteria for BD, including those age 18-25 with BSD.
        3. Control populations of: a) Healthy volunteer children and adolescents between the ages
        of 3-17 years old, b) Parents of healthy volunteer children or healthy adults in research,
        c) Children 8-17 years old with attention deficit hyperactivity disorder (ADHD), who do not
        have a mood disorder. 4. First and second-degree biological relatives of those in (B.1) or
        (B.2), above, and are between 3-58 years old. 5. A subgroup of these cohorts will be Old
        Order Amish individuals who fulfill eligibility for (1), (2), (3a), (3b), or (4).
      
Keywords: Emotion; Affective Neuroscience; Bipolar Disorder; Child; Child Bipolar; Natural History; BPD; Adolescent Bipolar