INCLUSION CRITERIA - CHILDREN WITH SEVERE MOOD AND BEHAVIORAL DYSREGULATION (all must be met):
1. Ages 7-17
2. 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).
3. Hyperarousal, as defined by at least three of the following symptoms: insomnia, agitation, distractibility, racing thoughts or flight of ideas, pressured speech, intrusiveness.
4. Compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifested 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 for the past four weeks.
5. 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.
6. The onset of symptoms must be prior to age 12 years.
7. The symptoms are severe in at least 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.
8. For medication taper only: The child is failing his/her treatment. To meet this criterion:
-The child's current CGAS score must be less than or equal to 60.
- The child's psychiatrist/treater must agree 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).
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:
1. 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 excessive involvement in pleasurable activities that have a high potential for painful consequences)
2. The symptoms occur in distinct periods lasting more than 4 days, and therefore meet criteria for hypomania or mania.
3. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.
4. Meets criteria for substance use disorder in the three months prior to randomization.
5. IQ less than 70.
6. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.
7. Currently pregnant or lactating, or sexually active without using a barrier method of contraception.
8. Subjects who are ineligible for MRI scanning (e.g. braces, implanted metal devices) will be excluded from the medication-discontinuation study.
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).
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 11/25/2009