Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
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|ClinicalTrials.gov Identifier: NCT00006177|
Recruitment Status : Recruiting
First Posted : August 14, 2000
Last Update Posted : October 19, 2017
|Condition or disease|
|Healthy Bipolar Disorder Mood Disorders|
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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:
- 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
- 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.
- to examine genetic and familial correlates of pediatric BSD
There are 11 separate populations being studied in this protocol:
- Children and adolescents between the ages of 6-17 years old who meet criteria for BSD.
- Adults between the ages of 18-58 years old who meet criteria for BD, including those age 18-25 with BSD.
- 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.
- First and second-degree biological relatives of those in (B.1) or (B.2), above, and are between 3-58 years old.
- A subgroup of these cohorts will be Old Order Amish individuals who fulfill eligibility for (1), (2), (3a), (3b), or (4).
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||2300 participants|
|Official Title:||The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents With Bipolar Disorder|
|Study Start Date :||August 11, 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006177
|Contact: Ellen Leibenluft, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Ellen Leibenluft, M.D.||National Institute of Mental Health (NIMH)|