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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00025935 |
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: | 280 |
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.
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):
For medication taper or lithium treatment trial only: The child is failing his/her treatment. To meet this criterion:
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 - CHILDREN WITH SEVERE MOOD AND BEHAVIORAL DYSREGULATION:
The individual exhibits any of these cardinal bipolar symptoms:
EXCLUSION CRITERIA - CONTROLS:
I.Q. less than 80; ongoing medical illness; neurologic disorder (including seizures); pregnancy; meeting past or present criteria for any diagnosis on the K-SADS-PL(7); meeting the criteria for severe mood and behavioral dysregulation; meeting criterion of post-traumatic stress disorder (exposure to a traumatic event).
CHILDREN ENTERING MEDICATION DISCONTINUATION STUDY:
Children may be eligible to be admitted to the Pediatric Behavioral Health Unit at the Clinical Center in order to have their medication discontinued and to undergo research procedures (i.e., neuropsychological testing and neuroimaging) for up to two weeks medication-free without entering the Li/placebo trial. Individuals entering this arm of the study will meet the same inclusion/exclusion criteria as for the Li/placebo trial above (i.e. full diagnostic criteria and CGAS less than or equal to 60) with the following modifications:
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 |
Study ID Numbers: | 020021, 02-M-0021 |
Study First Received: | October 31, 2001 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00025935 |
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 Conduct Disorder Mental Disorders Bipolar Disorder Mood Disorders |
Disease Progression Lithium Carbonate Psychotic Disorders Healthy Lithium |
Pathologic Processes Disease |