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Home > "C" Clinical Trials Conditions > Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study  Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
For Condition: Healthy
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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)
Details: Bipolar disorder (BPD) in children and adolescents is receiving increased research attention, but important questions remain about its phenomenology and about underlying neural mechanisms. This study has two specific aims: 1) to use longitudinal, objective techniques to characterize the clinical manifestations of early-onset bipolar illness; and 2) to identify neurophysiological correlates of affective dysregulation in bipolar children and adolescents. To accomplish Specific Aim #1, we will obtain prospective clinical data (including daily mood and behavioral ratings and actigraphy data) and direct observational data, and perform neuropsychological assessments. In addition, we will assess the psychiatric status of family members, bank genetic samples from patients and first-degree relatives for use in future studies, and follow the patients longitudinally (clinically and with structural MRI scans) for 4 years. To accomplish Specific Aim #2, we will use standardized emotional stimuli to test the hypothesis that responses to negative emotional stimuli are more pronounced in children with BPD than in controls. In addition, we will test the hypotheses that, relative to controls, prepulse inhibition is reduced in children with BPD, and anterior cortical asymmetry is more variable in children with BPD.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 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. INCLUSION CRITERIA - Controls: Control subjects will be age- and sex-matched to the patients. They will have normal physical and neurological examinations, and an identified primary care physician. Both control subjects and their first-degree relatives must be free of current or past psychopathology. EXCLUSION CRITERIA - Bipolar Patients: I.Q. less than 70; autistic disorder or severe pervasive developmental disorder; psychosis that interferes with the child's capacity to understand and comply with study procedures. Patients must not have an unstable medical illness (e.g., severe asthma). Patients must not have a medical illness that could cause the symptoms of bipolar illness (e.g., multiple sclerosis, thyroid disease). Patients must not be pregnant. Patients must not have engaged in substance abuse within two months of the initial evaluation. CONTROLS: Healthy normal volunteers. Control subjects will be age- and sex- matched to the patients. They will have normal physical and neurological examinations, and an identified primary care physician. Both control subjects and their first-degree relatives must be free of current or past psychopathology. Controls must have an I.Q. greater than or equal to 70. Controls must not have ongoing medical illness. Controls must not have neurologic disorder (including seizures). Controls must not be pregnant. Controls must not have engaged in past or present substance abuse. Controls must not have a history of sexual abuse.
Total Enrollment: 700
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 000198; 00-M-0198
Study Start Date: August 9, 2000
Record last reviewed: July 25, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006177
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Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
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