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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00025935 |
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 |
INCLUSION CRITERIA (all must be met):
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.
CHILDREN WITH SMD ENTERING TREATMENT:
In addition to criteria above, the child is failing his/her treatment as defined as:
EXCLUSION CRITERIA:
The individual exhibits any of these cardinal bipolar symptoms:
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: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00025935 History of Changes |
| Other Study ID Numbers: | 020021, 02-M-0021 |
| Study First Received: | October 31, 2001 |
| Last Updated: | December 24, 2011 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Bipolar Disorder Mood Disorders Affective Disorders, Psychotic Mental Disorders |