Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
- Conditions
- Bipolar DisorderMood DisordersAttention Deficit Hyerpactivity Disorder
- Registration Number
- NCT00006177
- Lead Sponsor
- National Institute of Mental Health (NIMH)
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1303
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective 1: clinical manifestations lifetime of protocol (1) clinical interviews \[e.g., Schedule for Affective Disorders and Schizophrenia for School-Age Children-present and lifetime version, K-SADS-PL, (Kaufman et al., 1997); Structured Clinical Interview for DSM-IV-TR Axis I Disorders, SCID (First et al., 2002)\]; (2) clinical and mood rating assessments (e.g., Children's Depression Rating Scale (Poznanski et al., 1984), Young Mania Rating Scale (Young et al., 1978), Pediatric Anxiety Rating (2002), EMA; (3) episode setting via detailed clinical interview at baseline and every 6 month follow up phone call (4) parent-report and self-report \[e.g., The Screen for Child Anxiety Related Emotional Disorders SCARED (Birmaher et al., 1997); Social Responsiveness Scale, SRS (Constantino et al., 2003, Granader et al.); Child Behavior Checklist CBCL (Achenbach, 1991)\].
Objective 2: behavioral, neuropsychological, neurophysiological, and neuroanatomical correlates lifetime of protocol 1) behavioral performance (e.g., accuracy, response time) on tasks assessing attention, emotion, and attention-emotion interactions; (e.g., Stop/Change task, CPT/Flanker, Decision Making tasks) 2) neuropsychological performance (e.g., performance and verbal IQ) 3) brain activation using functional MRI during tasks assessing attention, emotion, and attention-emotion interactions; 4) structural MRI to examine the size, shape and development of grey matter; 5) Diffusion Tensor Imaging (DTI) to measure white matter track myelination; 6) resting state imaging to test functional connectivity between prefrontal regions and the amygdala
Objective 3: genetic and familial correlates lifetime of protocol (1) clinical interviews \[e.g., Schedule for Affective Disorders and Schizophrenia for School-Age Children-present and lifetime version, K-SADS-PL, (Kaufman et al., 1997); Structured Clinical Interview for DSM-IV-TR Axis I Disorders, SCID (First et al., 2002)\] to examine the rate of various diagnoses in relatives of individuals with BD (2) genetic material to compare genetic polymorphisms in BSD, their relatives and controls (3) relationship between genetic material and performance on behavioral tasks and activation during fMRI paradigms (4) behavioral performance on standardized paradigms; brain activation using functional MRI; size, shape and development of several ROIs using structural MRI; Diffusion Tensor Imaging (DTI); and, Resting State in individuals with a BD relative
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States