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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00025935
First received: October 31, 2001
Last updated: November 23, 2016
Last verified: November 2016
  Purpose
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.

Condition Phase
Mood Disorder
Bipolar Disorder
Phase 4

Study Type: Observational
Official Title: Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in Children and Youth

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 950
Study Start Date: October 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 25 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • CHILDREN WITH SEVERE MOOD AND BEHAVIORAL DYSREGULATION (SMD) OR DMDD

INCLUSION CRITERIA (all must be met):

  1. Ages 7-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25.
  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 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.
  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 in 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.

    CHILDREN WITH SMD OR DMDD ENTERING TREATMENT. IN ADDITION TO CRITERIA ABOVE:

    • Has no exclusionary criteria for MRI scanning
    • the child is failing his/her treatment as defined as:

      • The child s current CGAS score less than or equal to 60.
      • The child s psychiatrist/treater agrees 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).

    EXCLUSION CRITERIA FOR THOSE WITH SMD OR DMDD:

    • 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 the excessive involvement in pleasurable activities that have a high potential for painful consequences)
      • Has BD symptoms in distinct periods lasting more than 1 day.
    • Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.
    • IQ< 70
    • The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.
    • Currently pregnant or lactating
    • Subjects who are ineligible for MRI scanning (e.g. braces, implanted metal devices) will be excluded from treatment.
    • Meets criteria for alcohol or substance abuse with the last three months.
    • NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.

    HEALTHY VOLUNTEER CONTROLS (Children):

    HEALTHY VOLUNTEER INCLUSION CRITERIA:

    Control subjects will be group matched to the patients.

    Have an identified primary care physician.

    Speaks English

    HEALTHY VOLUNTEER EXCLUSION CRITERIA:

    I.Q. < 70;

    Any serious medical condition or condition that interferes with fMRI scanning

    Pregnant or lactating;

    Past or current diagnosis of any anxiety disorder (panic disorder, GAD, Separation Anxiety Disorder, Social Phobia), mood disorder (manic or hypomanic episode, major depression), OCD, PTSD, Conduct Disorder, psychosis, current suicidal ideation, Tourette Disorder, Autism Spectrum Disorder or ADHD.

    Substance abuse within two months prior to study participation or present substance abuse

    History of sexual abuse.

    Parent or sibling with Bipolar Disorder, recurrent MDD, or any disorder with psychosis.

    NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.

    HEALTHY VOLUNTEER (ADULTS)

    INCLUSION CRITERIA:

    Control subjects will be group matched to the patients.

    They will have normal physical and neurological examinations by history or checklist

    Have an identified primary care physician.

    Speaks English

    EXCLUSION CRITERIA:

    IQ< 70

    Pregnant

    Any past or current history of Bipolar Disorder (any manic or hypomanic episode), recurrent MDD, or any disorder with psychosis

    NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.

    CHILDREN WITH MAJOR DEPRESSIVE DISORDER (MDD):

    Inclusion criteria (all must be met):

    Ages 12-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25.

    DSM-5 Major Depressive Disorder

    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.

    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.)

    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.

    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.

    Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day

    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

    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).

    Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings).

    Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g. appears easily distracted, complains of memory difficulties).

    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

    Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning.

    The episode is not attributable to the physiological effects of a substance or to another medical condition.

    Youth with MDD who are continuing in research as adults must also be receiving psychiatric care for their MDD, if it is ongoing

    CHILDREN WITH MDD ENTERING TREATMENT. IN ADDITION TO THE CRITERIA ABOVE, THE CHILD:

    Has no exclusionary criteria for MRI scanning

    Is failing his/her treatment as defined as:

    • The child s current CGAS score <60.
    • The child s psychiatrist/treater agrees 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).

    EXCLUSION CRITERIA FOR THOSE WITH MDD:

    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 the excessive involvement in pleasurable activities that have a high potential for painful consequences)
    • Has BD symptoms in distinct periods lasting more than 1 day.

    Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.

    IQ< 70

    The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.

    Currently pregnant or lactating

    Subjects who are ineligible for MRI scanning (e.g. braces, implanted metal devices) will be excluded from treatment.

    Meets criteria for alcohol or substance abuse with the last three months

    NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025935

Contacts
Contact: Ellen Leibenluft, M.D. (301) 496-9435 leibs@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Ellen Leibenluft, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00025935     History of Changes
Other Study ID Numbers: 020021  02-M-0021 
Study First Received: October 31, 2001
Last Updated: November 23, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
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

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 05, 2016