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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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2001 |
Recently, researchers and clinicians have focused increased attention on a group of children with severe mood and behavioral dysregulation. These children are characterized by impairing symptoms that include abnormal baseline mood (i.e. irritability, anger, and/or sadness), hyperarousal (e.g. insomnia, agitation, distractibility), and increased reactivity to negative emotional stimuli. Because this syndrome shares many clinical features with bipolar disorder (BPD), there is considerable debate as to whether these children should be diagnosed with BPD. However, children with this syndrome lack the cardinal symptoms of BPD (i.e. euphoria, elation, grandiosity, decreased need for sleep, and increased goal-directed activity). Similarly, while many of these children fit diagnostic criteria for other DSM-IV diagnoses (including attention deficit hyperactivity, oppositional defiant, major depressive and/or conduct disorders), these diagnoses capture heterogeneous clinical populations that include many children who do not exhibit the symptoms noted above. Therefore, the first goal of this project is to identify reliably a group of children with severe mood and behavioral dysregulation in order to characterize them clinically and follow them longitudinally. In addition, since there are no controlled trials to guide treatment of these severely impaired children, we will conduct a double-blinded, placebo controlled trial of lithium. The goals of this trial will be to test the efficacy of lithium, and to investigate whether lithium response, which has been associated with neurotrophic effects and with changes in phosphoinositide signaling in bipolar patients, has similar effects in this group of patients. Finally we will test two preliminary hypotheses regarding the possible pathophysiology of their symptoms. To do so, we will use affect-modulated startle techniques parallel to those being used in a study of children with unequivocal BPD (Protocol #00-M-0198) as well as functional MRI.
Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA - CHILDREN WITH SEVERE MOOD AND BEHAVIORAL DYSREGULATION (all must be met):
INCLUSION CRITERIA - CONTROLS:
Control subjects will be group 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 - CHILDREN WITH SEVERE MOOD AND BEHAVIORAL DYSREGULATION:
The individual exhibits any of these cardinal bipolar symptoms:
EXCLUSION CRITERIA - CONTROLS:
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 | |
More Information
| Study ID Numbers: | 020021, 02-M-0021 |
| Study First Received: | October 31, 2001 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00025935 History of Changes |
| 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 |
|
Affective Disorders, Psychotic Pathologic Processes Disease |
Mental Disorders Bipolar Disorder Mood Disorders |