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 range
7 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying brain function and the course of illness in kids with mood disorders — given that it's looking at things like brain anatomy, genetics, and irritability, what kinds of tests or scans would my child actually need to go through?
2Since this study is categorized as 'NA' for phase, which suggests it's an observational or natural history study rather than one testing a new treatment, does participating mean my child would receive any therapy or medication through the trial, or would we need to continue managing treatment separately?
3The trial is specifically measuring irritability alongside brain and behavioral patterns — if my child's irritability is one of the main symptoms we're struggling with, could taking part in this research help us better understand what's driving it, and is that something worth discussing with our care team?
4Because this study is still actively recruiting and focuses on pediatric bipolar disorder and mood disorders, what would the long-term commitment look like for our family in terms of follow-up visits and time?
5Are there standard clinical evaluations or treatments we should consider first before enrolling in an observational study like this, or could participating alongside regular care actually give us useful information sooner?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
.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.
. 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.