Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder (NCT00025935) | Clinical Trial Compass
RecruitingNot Applicable
Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
United States2,350 participantsStarted 2002-01-01
Plain-language summary
This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD) display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Researchers will describe the moods and behaviors of children with these symptoms and use specialized testing and brain imaging to learn about the brain changes associated with this disorder....
Who can participate
Age range7 Years – 60 Years
SexALL
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Inclusion criteria
✓. Inclusion criteria for children with DMDD, subthreshold DMDD:
✓.1.1 Ages 7-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25.
✓.1.2 Abnormal mood (specifically, anger, sadness, and/or irritability), present at least half of the day most days (or at least half the day at least one day per week for subthreshold), and of sufficient severity to be noticeable by people in the child's environment (e.g. parents, teachers, peers).
✓.1.3 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. For subthreshold DMDD such tantrums occur on average at least once per month.
✓.1.4 The symptoms in # 1.1.2, and 1.1.3 above are currently present and have been present for at least 12 months without any symptom-free periods exceeding three months.
✓.1.5 The onset of symptoms must be prior to age 10 years.
✓.1.6 For DMDD the symptoms are severe in at least in one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers) and at least mild (distractibility, intrusiveness) in a second setting. For subthreshold DMDD, there must be evidence of impairment causing distress to the child or to those around him/her in at least one setting.
What they're measuring
1
To examine between-group differences in clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables
Timeframe: 20 years
2
To examine associations between irritability and clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables
✓. Parents of children and adolescents with DMDD or subthreshold DMDD enrolled in 02-M-0021
Exclusion criteria
✕.3 Exclusion criteria for those with DMDD:
✕.3.1 The individual exhibits any of these cardinal bipolar symptoms:
✕.3.1.1 Elevated or expansive mood
✕.3.1.2 Grandiosity or inflated self-esteem
✕.3.1.3 Decreased need for sleep
✕.3.1.4 Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences)
✕.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day.
✕.3.2. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.