Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
|First Received Date ICMJE||August 12, 2000|
|Last Updated Date||July 11, 2017|
|Start Date ICMJE||August 9, 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006177 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study|
|Official Title ICMJE||The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents With Bipolar Disorder|
|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.|
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:
There are 11 separate populations being studied in this protocol:
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 2-year 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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||2300|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Inclusion and exclusion criteria for each group are outlined below. The total accrual ceiling is 2050, including subjects of both sexes, made up of the following 11 populations:
Pediatric patients with bipolar disorder or SMIBRD:
Adults with BD participating as individuals or as parents of at- risk children:
Healthy volunteer children and adolescents:
Parents of healthy volunteer children (Amish and Non-Amish) and Healthy Adults (not parents):
Control subjects with ADHD but not BD:
First- and Second-degree relatives of patients with BD:
Amish Community children with BD:
Amish Community Adults with BD:
Amish Community at-risk subjects:
Amish Community healthy volunteer children & adolescents:
Amish Community adults who are parents of healthy volunteer children & adolescents, healthy spouses of Amish adults with BD, or parents of adolescents with BD:
In addition, children with BD (Section B.1.) who wish to receive treatment, including discontinuation of medication while inpatients on the pediatric behavioral health unit at NIH, may be eligible for treatment if they meet the following additional criteria:
All inclusion criteria for B.1 (above)
Treatment failure as defined by current CGAS score <60
The child s psychiatrist/treating physician agrees that a change in medication regimen is appropriate
All exclusion criteria for B.1 (above)
Any contraindications for MRI scanning, plus claustrophobia or extreme separation anxiety
|Ages||42 Months to 17 Years (Child)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00006177|
|Other Study ID Numbers ICMJE||000198
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 30, 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP