RECRUITING

Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder

Conditions

Mood Disorder Neuroimaging Conduct Disorder Children and Adolescents Affective Neuroscience Natural History Behavioral Dysregulation Behavior Children Adolescent Healthy Volunteer HV Normal Control

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in Children and Youth

Quick Facts

Study Start:2002-01-01

Study Completion:N/A

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT00025935

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Inclusion criteria for children with DMDD, subthreshold DMDD: 1.1.1 Ages 7-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25. 1.1.2 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). 1.1.3 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. 1.1.4 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. 1.1.5 The onset of symptoms must be prior to age 10 years. 1.1.6 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. 2. Parents of children and adolescents with DMDD or subthreshold DMDD enrolled in 02-M-0021 2.1.1. Are capable of performing behavioral tasks and/or scanning. 2.1.2. Speaks English 3. Healthy Volunteer (Control) Children 3.1.1. Control subjects will be group matched to the patients. 3.1.2. Have an identified primary care physician. 3.1.3. Speaks English 4. Healthy Volunteer Adults 4.1.1 Control subjects will be group matched to the patients. 4.1.2. They will have normal physical and neurological examinations by history or checklist 4.1.3. Have an identified primary care physician. 4.1.4 Speaks English 5. Children with Major Depressive Disorder (MDD) Inclusion criteria (all must be met): 5.1.1 Ages 11-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25. 5.1.2. DSM-IV or DSM-5 Major Depressive Disorder 5.1.2.1 Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. 5.1.2.1.1 Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feeling sad, blue, "down in the dumps," or empty) or observation made by others (e.g., appears tearful or about to cry). (In children and adolescents, this may present as an irritable or cranky, rather than sad, mood.) 5.1.2.1.2 Markedly diminished interest or pleasure in all, or almost all, activities every day, such as no interest in hobbies, sports, or other things the person used to enjoy doing. 5.1.2.1.3. Significant weight loss when not dieting or weight gain (e.g., a change of more than 5 percent of body weight in a month), or decrease or increase in appetite nearly every day. 5.1.2.1.4. Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day 5.1.2.1.5. Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, pulling at clothes or clothes) or retardation (e.g., slowed speech, movements, quiet talking) nearly every day 5.1.2.1.6. Fatigue, tiredness, or loss of energy nearly every day (e.g., even the smallest tasks, like dressing or washing, seem difficult to do and take longer than usual). 5.1.2.1.7. Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings). 5.1.2.1.8. Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g. appears easily distracted, complains of memory difficulties). 5.1.2.1.9. Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideas without a specific plan, or a suicide attempt or a specific plan for committing suicide 5.1.2.1.10 Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning. 5.1.2.1.11. The episode is not attributable to the physiological effects of a substance or to another medical condition. 5.1.3. Youth with MDD who are continuing in research as adults must also be receiving psychiatric care for their MDD, if it is ongoing 6. Children with Attention-Deficit/Hyperactivity Disorder (ADHD) 6.1.1. Age 8-17 6.1.2. Currently meets DSM-IV or DSM-5 criteria for ADHD 6.1.3. Subjects with other primary psychiatric disorders including anxiety disorders, dysthymic disorder, past major depression, oppositional defiant disorder, tic disorders, and the learning, communication, and elimination disorders may be accepted 6.1.4. Have an identified primary care physician. 6.1.5. Speaks English	1.3 Exclusion criteria for those with DMDD: 1.3.1 The individual exhibits any of these cardinal bipolar symptoms: 1.3.1.1 Elevated or expansive mood 1.3.1.2 Grandiosity or inflated self-esteem 1.3.1.3 Decreased need for sleep 1.3.1.4 Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences) 1.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day. 1.3.2. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD. 1.3.3. IQ\< 70 1.3.4. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition. 1.3.5. Currently pregnant or lactating 1.3.6. Meets criteria for alcohol or substance abuse with the last three months 2. Exclusion of parents of children and adolescents with DMDD or subthreshold DMDD 2.1 Have an I.Q. \< 70 2.2 Have any serious medical condition or condition that interferes with participation 3.2 Healthy Volunteer

Inclusion Criteria

Exclusion Criteria

1. Inclusion criteria for children with DMDD, subthreshold DMDD:
1.1.1 Ages 7-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25.
1.1.2 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).
1.1.3 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.
1.1.4 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.
1.1.5 The onset of symptoms must be prior to age 10 years.
1.1.6 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.
2. Parents of children and adolescents with DMDD or subthreshold DMDD enrolled in 02-M-0021
2.1.1. Are capable of performing behavioral tasks and/or scanning.
2.1.2. Speaks English
3. Healthy Volunteer (Control) Children
3.1.1. Control subjects will be group matched to the patients.
3.1.2. Have an identified primary care physician.
3.1.3. Speaks English
4. Healthy Volunteer Adults
4.1.1 Control subjects will be group matched to the patients.
4.1.2. They will have normal physical and neurological examinations by history or checklist
4.1.3. Have an identified primary care physician.
4.1.4 Speaks English
5. Children with Major Depressive Disorder (MDD) Inclusion criteria (all must be met):
5.1.1 Ages 11-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25.
5.1.2. DSM-IV or DSM-5 Major Depressive Disorder
5.1.2.1 Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.
5.1.2.1.1 Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feeling sad, blue, "down in the dumps," or empty) or observation made by others (e.g., appears tearful or about to cry). (In children and adolescents, this may present as an irritable or cranky, rather than sad, mood.)
5.1.2.1.2 Markedly diminished interest or pleasure in all, or almost all, activities every day, such as no interest in hobbies, sports, or other things the person used to enjoy doing.
5.1.2.1.3. Significant weight loss when not dieting or weight gain (e.g., a change of more than 5 percent of body weight in a month), or decrease or increase in appetite nearly every day.
5.1.2.1.4. Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day
5.1.2.1.5. Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, pulling at clothes or clothes) or retardation (e.g., slowed speech, movements, quiet talking) nearly every day
5.1.2.1.6. Fatigue, tiredness, or loss of energy nearly every day (e.g., even the smallest tasks, like dressing or washing, seem difficult to do and take longer than usual).
5.1.2.1.7. Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings).
5.1.2.1.8. Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g. appears easily distracted, complains of memory difficulties).
5.1.2.1.9. Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideas without a specific plan, or a suicide attempt or a specific plan for committing suicide
5.1.2.1.10 Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning.
5.1.2.1.11. The episode is not attributable to the physiological effects of a substance or to another medical condition.
5.1.3. Youth with MDD who are continuing in research as adults must also be receiving psychiatric care for their MDD, if it is ongoing
6. Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
6.1.1. Age 8-17
6.1.2. Currently meets DSM-IV or DSM-5 criteria for ADHD
6.1.3. Subjects with other primary psychiatric disorders including anxiety disorders, dysthymic disorder, past major depression, oppositional defiant disorder, tic disorders, and the learning, communication, and elimination disorders may be accepted
6.1.4. Have an identified primary care physician.
6.1.5. Speaks English

1.3 Exclusion criteria for those with DMDD:
1.3.1 The individual exhibits any of these cardinal bipolar symptoms:
1.3.1.1 Elevated or expansive mood
1.3.1.2 Grandiosity or inflated self-esteem
1.3.1.3 Decreased need for sleep
1.3.1.4 Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences)
1.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day.
1.3.2. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.
1.3.3. IQ\< 70
1.3.4. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.
1.3.5. Currently pregnant or lactating
1.3.6. Meets criteria for alcohol or substance abuse with the last three months
2. Exclusion of parents of children and adolescents with DMDD or subthreshold DMDD
2.1 Have an I.Q. \< 70
2.2 Have any serious medical condition or condition that interferes with participation
3.2 Healthy Volunteer

Contacts and Locations

Study Contact

Melissa A Brotman, Ph.D.

CONTACT

(301) 435-6645

melissa.brotman@nih.gov

Principal Investigator

Melissa A Brotman, Ph.D.

PRINCIPAL_INVESTIGATOR

National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

Melissa A Brotman, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2002-01-01

Study Completion DateN/A

Study Record Updates

Study Start Date2002-01-01

Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

Neuroimaging
Mood Disorder
Conduct Disorder
Children and Adolescents
Affective Neuroscience
Natural History
Behavioral Dysregulation
Behavior
Children
Adolescent
Healthy Volunteer
HV
Normal Control

Additional Relevant MeSH Terms

Mood Disorder