Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
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Purpose
We study the course of child bipolar illness and how brain function differs between youth with bipolar disorder, those 'at-risk,' and healthy volunteers.
| Study Type: | Observational |
| Official Title: | Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in Children and Youth |
Eligibility| Ages Eligible for Study: | 7 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- CHILDREN WITH SEVERE MOOD AND BEHAVIORAL DYSREGULATION (SMD)
INCLUSION CRITERIA (all must be met):
- Ages 7-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25.
- Abnormal mood (specifically, anger, sadness, and/or irritability), present at least half of the day most days, and of sufficient severity to be noticeable by people in the child's environment (e.g. parents, teachers, peers).
- Hyperarousal, as defined by at least three of the following symptoms: insomnia, agitation, distractibility, racing thoughts or flight of ideas, pressured speech, intrusiveness
Compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. Such events occur, on average, at least three times a week.
- The symptoms in # 2, 3, and 4 above are currently present and have been present for at least 12 months without any symptom-free periods exceeding two months.
- The onset of symptoms must be prior to age 12 years.
- The symptoms are severe in at least in one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers). In addition, there are at least mild symptoms (distractibility, intrusiveness) in a second setting.
CHILDREN WITH SMD ENTERING TREATMENT:
In addition to criteria above, the child is failing his/her treatment as defined as:
- The child's current CGAS score < 60.
- The child's psychiatrist/treater agrees that the child's response to his/her current treatment makes it clinically appropriate to change the child's current treatment.
- On the basis of record review and interviews with child and parent, the research team agrees that the child's response to his/her current treatment is no more than minimal (i.e. CGI-I> 2).
EXCLUSION CRITERIA:
The individual exhibits any of these cardinal bipolar symptoms:
- Elevated or expansive mood
- Grandiosity or inflated self-esteem
- Decreased need for sleep
- Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences)
- Has BD symptoms in distinct periods lasting more than 1 day.
Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.
IQ< 70
The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.
Currently pregnant or lactating
Subjects who are ineligible for MRI scanning (e.g. braces, implanted metal devices) will be excluded from treatment.
Meets criteria for alcohol or substance abuse with the last three months.
HEALTHY VOLUNTEER CONTROLS:
INCLUSION CRITERIA:
Control subjects will be group matched to the patients.
They will have normal physical and neurological examinations by history or checklist,
Have an identified primary care physician.
Control subjects must be free of current or past psychopathology and their first-degree relatives must be free of a mood or anxiety disorder.
EXCLUSION CRITERIA:
I.Q. < 70;
ongoing medical illness;
neurologic disorder (including seizures);
pregnant or lactating;
meeting past or present criteria for any diagnosis on the K-SADS-PL
meeting the criteria for severe mood and behavioral dysregulation noted above;
meeting criterion A of post-traumatic stress disorder (exposure to a traumatic event)
Alcohol or substance abuse in the last 3 months
Contacts and Locations| Contact: Ellen Leibenluft, M.D. | (301) 496-9435 | leibs@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Ellen Leibenluft, M.D. | National Institute of Mental Health (NIMH) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00025935 History of Changes |
| Other Study ID Numbers: | 020021, 02-M-0021 |
| Study First Received: | October 31, 2001 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Mood Disorders Bipolar Disorder Neuroimaging Psychophysiology Frustration Emotional Dysregulation Lithium Conduct Disorder Children and Adolescents |
Affective Neuroscience Behavioral Dysregulation Mood Disorder Behavior Children Adolescent Healthy Volunteer HV Normal Control |
Additional relevant MeSH terms:
|
Bipolar Disorder Mood Disorders Affective Disorders, Psychotic Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013