Trial record 11 of 1098 for:    Open Studies | "Mood Disorders"

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

This study is currently recruiting participants.
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00025935
First received: October 31, 2001
Last updated: April 11, 2014
Last verified: February 2014
  Purpose

We study the course of child bipolar illness and how brain function differs between youth with bipolar disorder, those 'at-risk,' and healthy volunteers.


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: 850
Study Start Date: October 2001
  Show Detailed Description

  Eligibility

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

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.

    • 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.
    • The onset of symptoms must be prior to age 12 years.
    • 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 ENTERING TREATMENT:

    In addition to criteria above, the child 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:

    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.

    HEALTHY VOLUNTEER CONTROLS:

    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.

    Control subjects must be free of current or past psychopathology and their first-degree relatives must be free of a mood or anxiety disorder.

    EXCLUSION CRITERIA:

    I.Q. < 70;

    ongoing medical illness;

    neurologic disorder (including seizures);

    pregnant or lactating;

    meeting past or present criteria for any diagnosis on the K-SADS-PL

    meeting the criteria for severe mood and behavioral dysregulation noted above;

    meeting criterion A of post-traumatic stress disorder (exposure to a traumatic event)

    Alcohol or substance abuse in the last 3 months

  Contacts and Locations
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
Investigators
Principal Investigator: Ellen Leibenluft, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00025935     History of Changes
Other Study ID Numbers: 020021, 02-M-0021
Study First Received: October 31, 2001
Last Updated: April 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Mood Disorders
Mood Disorder
Bipolar Disorder
Neuroimaging
Psychophysiology
Frustration
Emotional Dysregulation
Lithium
Conduct Disorder
Children and Adolescents
Affective Neuroscience
Behavioral Dysregulation
Behavior
Children
Adolescent
Healthy Volunteer
HV
Normal Control

Additional relevant MeSH terms:
Bipolar Disorder
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014