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Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
This study is currently recruiting participants.
Verified March 2011 by National Institutes of Health Clinical Center (CC)

First Received on August 12, 2000.   Last Updated on December 24, 2011   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00006177
  Purpose

The National Institute of Mental Health is seeking boys and girls ages 6 to 17 with bipolar disorder who are not doing well on their current medication(s) to participate in a research study. The study includes outpatient assessment, full or partial hospitalization, discontinuation of all current medications, fMRI scanning (a form of brain imaging), and starting new medications at the NIH Clinical Center in Bethesda, MD. No novel or experimental treatments are part of this study. Participants will receive a thorough clinical evaluation.

Participants must be:

In treatment for bipolar disorder with a psychiatrist who agrees that it is appropriate for the child to participate in the study

Psychiatrically unstable on current medications

Able to fill out daily self rating forms and cooperate with study procedures (includes genetics study, MRI, neuropsychological and behavioral testing, and others)


Condition
Healthy
Bipolar Disorder

Study Type: Observational
Official Title: The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 2050
Study Start Date: August 2000
Detailed Description:

Bipolar disorder (BD) 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 BD, this study has four objectives:

  1. to use longitudinal techniques to characterize the clinical and physiological manifestations of pediatric BD, and to use cross-sectional techniques (e.g., comparing children and adults with BD 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 BD, 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 BD
  4. to ascertain the effects of sleep manipulation on mood, behavior, and amygdala activity in patients versus controls
  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Bipolar patients: Boys and girls must be ages 6-17 and meet DSM-IV criteria for bipolar disorder. The child must have a primary caregiver who can accompany him or her on trips to NIMH, provide reliable history and information, and complete daily rating scales and sleep logs. Patients must have a psychiatrist who provides clinical care for their BPD. All youth accepted into the study must be able to complete self-rating forms and to cooperate with other study procedures. Subjects must be on a stable medication regimen for at least 14 days prior to enrollment in the study. In addition, they, their parents, and treating physician must agree to keep medications stable (with the exception of minor dosage adjustments) until the end of the second NIMH evaluation, if clinically feasible and acceptable. The total duration of the medication-stable period will be approximately six weeks.

Controls: Control subjects will be age-and sex-matched to the patients. They will have no significantly abnormal physical and neurological examinations by history, and an identified primary care physician. Both control subjects and their first-degree relatives must be free of current or past psychopathology.

Children with ADHD: Children with ADHD will be: age 7-17, currently meets DSM-IV criteria for ADHD (this will be determined by a K-SADS interview), tscore greater than 65 on the Connors Teacher and the Connors Parent scales, and in treatment for the illness with a physician.

Children with BPD for Discontinuation of Medication with fMRI: Individuals will meet criteria for BPD, as above. The criteria for treatment failure will be: 1) the child's current CGAS score is less than or equal to 60, and 2) the child's psychiatrist agrees that a change in medication regimen is justified clinically.

Children at Risk for BPD: Children age 3-17 with a parent or a sibling diagnosed with BPD.

Amish Community Children at risk for BPD: Children age 8-17 with a parent or sibling (first-degree relative) diagnosed with BPD.

Amish Community Healthy Volunteer Children: children 8-17 without significant abnormal physical and neurological examinations (by history). Both control subjects and their first-degree relatives must be free of current or past psychopathology.

Parents of healthy volunteer children: Parents, age 25-65

Adult Bipolar adults for fMRI only, or as parents of at risk children: Adult Bipolar Patients will meet inclusion criteria based on their ability to participate in fMRI scanning safely and their eligibility for protocols 80-M-0083, and for other protocols in MAP that are recruiting bipolar adults (including 02-M-0018, 37, 85, 92. 176, and others), as indicated below.

Extended Relatives of At-Risk Parents/Children: Inclusion criteria will include individuals age 7-65 who are first, second, or third degree relatives of patients with bipolar disorder or of individuals at risk for bipolar disorder.

EXCLUSION CRITERIA

Bipolar patients: I.Q. less than 70; autistic disorder or severe pervasive development disorder; psychosis that interferes with the child's capacity to understand and comply with study procedures; unstable medical illness (e.g. severe asthma); medical illness that could cause the symptoms of bipolar illness (e.g. multiple sclerosis, thyroid disease); pregnancy; or substance abuse within two months of the initial evaluation.

Controls: I.Q. less than 70; ongoing medical illness; neurological disorder (including seizures); pregnancy; past or present substance abuse; history of sexual abuse.

Amish Child Controls: I.Q. < 70; limitations with English that compromise understanding consent/assent or task instructions; ongoing medical illness; neurological disorder (including seizures); pregnancy; past or present substance abuse; history of sexual abuse.

Discontinuation of Medication with fMRI: In addition to exclusion criteria for Bipolar patients, the presence of dental braces or extreme separation anxiety.

Parents of healthy volunteer children: IQ less than 70; ongoing medical illness; neurological disorder (including seizures); pregnancy; past or present substance abuse; history of sexual abuse, history of specific Axis I psychiatric disorders.

Extended Relatives of At-Risk Parents/Children: Exclusion criteria will include: (1) active psychosis, (2) dementia, (3) IQ less than 70, (4) any clinical condition in need of immediate care, (5) any chromic medical illness resulting in impaired CNS function, or (6) any condition that would interfere with the participants' ability to perform the research tasks.

Children with ADHD: IQ less than 80; pregnancy; medical illness or neurological disorder other than ADHD; contraindication to discontinuing medication for 72 hours; contraindication to fMRI scanning; any other psychiatric disorder that is sufficiently severe to require specific treatment, with the exception of oppositional defiant disorder, and the learning, communication, and elimination disorders.

At-Risk Amish Parents/Children: (1) active psychosis, (2) dementia,

(3) IQ< 70, (4) any clinical condition in need of immediate care, (5) any chronic medical illness resulting in impaired CNS function, or (6) any condition that would interfere with the participants' ability to perform the research tasks; (7) limitations with English that would interfere with understanding consent/assent or task instructions.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006177

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact            
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006177     History of Changes
Other Study ID Numbers: 000198, 00-M-0198
Study First Received: August 12, 2000
Last Updated: December 24, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Emotion
Children and Adolescents
Affective Neuroscience
Bipolar Disorder
Child
Child Bipolar
BPD
Adolescent Bipolar

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012