Viewing Study NCT00006177



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00006177
Status: COMPLETED
Last Update Posted: 2023-03-17
First Post: 2000-08-12

Brief Title: Child Adolescent Bipolar Disorder Brain Imaging and Treatment Study
Sponsor: National Institute of Mental Health NIMH
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents With Bipolar Disorder
Status: COMPLETED
Status Verified Date: 2023-03-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 SubstanceMedication-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 eg 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 B1 or B2 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 ie Bipolar Disorder or those with SubstanceMedication-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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
00-M-0198 None None None