Full Text View
Tabular View
No Study Results Posted
Related Studies
Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), August 2009
First Received: October 31, 2001   Last Updated: February 3, 2010   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00025935
  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 IV

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: 500
Study Start Date: October 2001
Detailed Description:

Recently, researchers and clinicians have focused increased attention on a group of children with severe mood and behavioral dysregulation. These children are characterized by impairing symptoms that include abnormal baseline mood (i.e. irritability, anger, and/or sadness), hyperarousal (e.g. insomnia, agitation, distractibility), and increased reactivity to negative emotional stimuli. Because this syndrome shares many clinical features with bipolar disorder (BPD), there is considerable debate as to whether these children should be diagnosed with BPD. However, children with this syndrome lack the cardinal symptoms of BPD (i.e. euphoria, elation, grandiosity, decreased need for sleep, and increased goal-directed activity). Similarly, while many of these children fit diagnostic criteria for other DSM-IV diagnoses (including attention deficit hyperactivity, oppositional defiant, major depressive and/or conduct disorders), these diagnoses capture heterogeneous clinical populations that include many children who do not exhibit the symptoms noted above. Therefore, the first goal of this project is to identify reliably a group of children with severe mood and behavioral dysregulation in order to characterize them clinically and follow them longitudinally. In addition, since there are no controlled trials to guide treatment of these severely impaired children, we will conduct a double-blinded, placebo controlled trial of lithium. The goals of this trial will be to test the efficacy of lithium, and to investigate whether lithium response, which has been associated with neurotrophic effects and with changes in phosphoinositide signaling in bipolar patients, has similar effects in this group of patients. Finally we will test two preliminary hypotheses regarding the possible pathophysiology of their symptoms. To do so, we will use affect-modulated startle techniques parallel to those being used in a study of children with unequivocal BPD (Protocol #00-M-0198) as well as functional MRI.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA - CHILDREN WITH SEVERE MOOD AND BEHAVIORAL DYSREGULATION (all must be met):

    1. Ages 7-17
    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 manifested 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 the past four weeks.
    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 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.
    8. For medication taper only: The child is failing his/her treatment. To meet this criterion:
  • The child's current CGAS score must be less than or equal to 60.
  • The child's psychiatrist/treater must agree 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).

INCLUSION CRITERIA - CONTROLS:

Control subjects will be group matched to the patients. They will have normal physical and neurological examinations, and an identified primary care physician. Both control subjects and their first-degree relatives must be free of current or past psychopathology.

EXCLUSION CRITERIA - CHILDREN WITH SEVERE MOOD AND BEHAVIORAL DYSREGULATION:

  1. 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 excessive involvement in pleasurable activities that have a high potential for painful consequences)
  2. The symptoms occur in distinct periods lasting more than 4 days, and therefore meet criteria for hypomania or mania.
  3. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.
  4. IQ less than 70.
  5. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.
  6. Currently pregnant or lactating, or sexually active without using a barrier method of contraception.
  7. Subjects who are ineligible for MRI scanning (e.g. braces, implanted metal devices) will be excluded from the medication-discontinuation study.

EXCLUSION CRITERIA - CONTROLS:

  1. I.Q. less than 80;
  2. ongoing medical illness;
  3. neurologic disorder (including seizures);
  4. pregnancy;
  5. meeting past or present criteria for any diagnosis on the K-SADS-PL(7);
  6. meeting the criteria for severe mood and behavioral dysregulation;
  7. meeting criterion of post-traumatic stress disorder (exposure to a traumatic event).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025935

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 020021, 02-M-0021
Study First Received: October 31, 2001
Last Updated: February 3, 2010
ClinicalTrials.gov Identifier: NCT00025935     History of Changes
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:
Affective Disorders, Psychotic
Pathologic Processes
Disease
Mental Disorders
Bipolar Disorder
Mood Disorders

ClinicalTrials.gov processed this record on February 08, 2010