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View Clinical Trial (Medical Research Study)
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Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study - NCT00006177-02115 (Clinical Trial 112734)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy112734.aspx
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| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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Healthy - Bipolar Disorder |
| Purpose: |
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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)...
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| Study summary: |
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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
to obtain genetic and family data; and 2) to identify behavioral, neuropsychological and
neurophysiological correlates of affective dysregulation in bipolar children and
adolescents. To accomplish Specific Aim #1, we will obtain prospective clinical data,
following patients longitudinally (clinically and with structural MRI scans) for 4 years.
In addition, we will assess the psychiatric status of family members, and bank genetic
samples from patients and first-degree relatives for use in future studies. 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 and to
children with other psychopathology, children with BPD have distinct deficits in reward
systems and in social information processing. Finally, we hypothesize that children who are
at risk for BPD will have deficits similar to those exhibited by children with BPD. |
| Criteria: |
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- INCLUSION AND EXCLUSION 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. Exclusion criteria will be 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.
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.
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.
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. |
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| Study is available at: |
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Harvard University
Boston, MA 02115
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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