Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study

This study is currently recruiting participants.
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006177
First received: August 12, 2000
Last updated: March 14, 2014
Last verified: September 2013

August 12, 2000
March 14, 2014
August 2000
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Complete list of historical versions of study NCT00006177 on ClinicalTrials.gov Archive Site
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Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents With Bipolar Disorder

The National Institute of Mental Health is seeking boys and girls ages 6 to 17 with bipolar disorder who are not doing well on their current medication(s) to participate in a research study. The study includes outpatient assessment, full or partial hospitalization, discontinuation of all current medications, fMRI scanning (a form of brain imaging), and starting new medications at the NIH Clinical Center in Bethesda, MD. No novel or experimental treatments are part of this study. Participants will receive a thorough clinical evaluation.

Participants must be:

In treatment for bipolar disorder with a psychiatrist who agrees that it is appropriate for the child to participate in the study

Psychiatrically unstable on current medications

Able to fill out daily self rating forms and cooperate with study procedures (includes genetics study, MRI, neuropsychological and behavioral testing, and others)

Objective:

Bipolar disorder (BD) in children and adolescents is receiving increased research attention, but important questions remain about its developmental trajectory, phenomenology and behavioral correlates, and little is known about its underlying neural mechanisms. In its study of youth with BD, this study has three objectives:

  1. to use longitudinal techniques to characterize the clinical and physiological manifestations of pediatric BD, and to use cross-sectional techniques (e.g., comparing children and adults with BD on these measures) to provide preliminary data to guide such longitudinal studies
  2. to identify and follow longitudinally behavioral, neuropsychological, neurophysiological, and neuroanatomical correlates of pediatric BD, and compare to children with chronic irritability and hyperarousal symptoms (severe mood dysregulation, SMD, as outlined in protocol 02-M-0021), youth with attention deficit hyperactivity disorder (ADHD), and typically developing youth.
  3. to examine genetic and familial correlates of pediatric BD

Study population:

There are 11 separate populations being studied in this protocol:

  1. Children and adolescents between the ages of 7-17 years old who meet criteria for BD.
  2. Adults between the ages of 18-58 years old who meet criteria for BD.
  3. Control populations of: a) Healthy volunteer children and adolescents between the ages of 3-17 years old, b) Parents of healthy volunteer children or healthy adults in research, c) Children 8-17 years old with attention deficit hyperactivity disorder (ADHD), who do not have a mood disorder.
  4. First and second-degree biological relatives of those in (B.1) or (B.2), above, and are between 3-58 years old.
  5. A subgroup of these cohorts will be Old Order Amish individuals who fulfill eligibility for (1), (2), (3a), (3b), or (4).

Design:

For children and adolescents with BD, this study is an outpatient characterization and longitudinal follow-along design. Once determined to be eligible, individuals come for an initial assessment, and then at 2-year intervals they return for clinical interviews, behavioral tasks, and structural and functional MRI.

For children and adolescents who are relatives of individuals with BD, this is an outpatient follow-along design during which individuals come for an outpatient assessment and at 2-year intervals for clinical interviews, behavioral tasks, and structural and functional MRI.

For healthy volunteer children, children with only ADHD, adults with BD, and parents of healthy volunteer children, this study is an outpatient cross-sectional study that includes clinical interviews, behavioral tasks, and structural and functional MRI.

For all others, individuals come to NIH for clinical interviews, behavioral tasks, and MRI.

For most individuals in the Amish community, the investigation occurs in the field, where they receive clinical interviews and behavioral tasks. Some may choose to come to the NIH to participate in behavioral testing and MRI.

For all individuals, genetic material from saliva or blood is obtained under protocol 01-M-0254.

Observational
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  • Healthy
  • Bipolar Disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2200
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  • INCLUSION AND EXCLUSION CRITERIA:

Inclusion and exclusion criteria for each group are outlined below. The total accrual ceiling is 2050, including subjects of both sexes, made up of the following 11 populations:

Pediatric patients with bipolar disorder:

INCLUSION CRITERIA:

Age 6-17

Meet DSM-IV criteria for BD

Have a primary caregiver who can accompany him or her on trips to NIMH and provide reliable history and information.

Have a psychiatrist who provides clinical care for their BD.

Be able to complete self-rating forms and to cooperate with other study procedures.

EXCLUSION CRITERIA:

I.Q. < 70

Autistic disorder or more than mild autism spectrum disorder;

Psychosis that interferes with the child s capacity to understand and comply with study procedures

Unstable medical illness (e.g. severe asthma)

Medical illness that could cause the symptoms of BD (e.g. multiple sclerosis, thyroid disease)

Pregnancy

Substance abuse within two months of the initial evaluation, since alcohol and abused substances interfere with interpretation of fMRI and cognitive task data.

Adults with BD participating as individuals or as parents of at- risk children:

INCLUSION CRITERIA:

DSM-IV Bipolar Disorder

Age 18-58

Be able to complete self-rating forms and to cooperate with other study procedures.

Medically safe to perform MRI

EXCLUSION CRITERIA:

Diagnosis of schizophrenia or other current psychosis.

Claustrophobia or anxiety that prevents participation in MRI

Any serious medical illness, such as heart, liver, or kidney disease.

A history of drug or alcohol abuse in the past 90 days.

Current or past seizure disorder

Currently unstable hyperthyroidism or hypothyroidism

Currently receiving medical treatment that would affect mood, such as steroids

Pregnant or breast-feeding.

Active suicidal or homicidal thoughts or plans

Healthy volunteer children and adolescents:

INCLUSION CRITERIA:

Age- and sex- matched to the bipolar patients.

No DSM-IV psychiatric diagnosis past or present, except substance abuse, per below

Have an identified primary care physician.

EXCLUSION CRITERIA

I.Q. < 70

Serious physical or neurological symptoms or disorder by history

Pregnancy

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

History of sexual abuse.

Past or present mood disorder in first-degree relative

Parents of healthy volunteer children (Amish and Non-Amish) and Healthy Adults (not parents):

INCLUSION CRITERIA:

For healthy adults (not parents): Healthy adults age 25-58

For parents of healthy volunteers: Parents of control subjects as outlined in B above

Age 25-58

EXCLUSION CRITERIA:

IQ< 70

Ongoing medical illness

Neurological disorder (including seizures)

Pregnancy

Past or present substance abuse

History of sexual abuse

History of Psychosis (current or past), Schizophrenia, Schizoaffective disorder, Any psychotic disorder: delusional, substance induced, due to a medical condition, or NOS, Major depressive disorder (current or past), Bipolar disorder , MDD NOS (current or past), BD NOS (current or past), Dysthymic Disorder (current or past), Cyclothymic Disorder (current or past), Any mood disorder: incl. (current or past) substance induced, due to a medical condition, ETOH/substance dependence (current or past), Panic Disorder (current or past), OCD (current or past), Generalized anxiety disorder (current or past), Social phobia, PTSD (current or past), Tic disorder (current), ADD/ADHD (current or past), Suicidality (current) , Suicide attempt (past), All Impulse control disorders, Dementia/ IQ < 80/ Developmental disorder, Chronic medical condition (seizure disorder, heart condition, diabetes, liver problems, thyroid problems, migraines, neurological problems), Eating disorder (current), Anorexia (current or lifetime), Somatoform disorders- somatization disorder; Pain disorder; Undifferentiated somatoform disorder; Hypochondriasis; Body dysmorphic disorder.

Control subjects with ADHD but not BD:

INCLUSION CRITERIA:

Age 8-17

Currently meets DSM-IV criteria for ADHD

t score > 65 on the Connors Parent scales

In treatment for ADHD with a physician

Subjects with other 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

EXCLUSION CRITERIA

IQ< 70

Pregnancy

Ongoing medical illness or neurological disorder other than ADHD

Contraindication to discontinuing medication for 72 hours

Any condition that would interfere with the participants ability to perform fMRI or other research tasks

Current Major Depression

Any past or present manic or hypomanic episode.

First- and Second-degree relatives of patients with BD:

INCLUSION CRITERIA:

First degree relatives (parent or sibling) or second-degree relative (grandparent, grandchild, uncle, aunt, nephew, niece, half-sibling) of patients with BD

Age 3-58

EXCLUSION CRITERIA:

Active psychosis

Dementia

IQ < 70

Any clinical condition in need of immediate care

Any chronic medical illness resulting in impaired CNS function

Any condition that interferes with the participants ability to perform research tasks

Amish Community children with BD:

INCLUSION CRITERIA:

Age 8-17

Meet DSM-IV criteria for BD

Have a primary caregiver who can provide a reliable history

Be able to complete self-rating forms and to cooperate with other study procedures.

EXCLUSION CRITERIA:

IQ< 70

Active psychosis

Any clinical condition in need of immediate care

Any chronic medical illness resulting in impaired CNS function

Any condition that would interfere with the participants ability to perform behavioral research tasks

Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.

Amish Community Adults with BD:

INCLUSION CRITERIA:

DSM-IV Bipolar Disorder

Age 18-58

Be able to complete self-rating forms and to cooperate with other study procedures.

EXCLUSION CRITERIA:

Diagnosis of schizophrenia or other current psychosis.

Any serious medical illness, such as heart, liver, or kidney disease.

A history of drug or alcohol abuse in the past 90 days.

Current or past seizure disorder

Currently unstable hyperthyroidism or hypothyroidism

Currently receiving medical treatment that would affect mood, such as steroids

Active suicidal or homicidal thoughts or plans

Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.

Amish Community at-risk subjects:

INCLUSION CRITERIA:

Age 8-17

Parent or sibling (first-degree relative) diagnosed with BD

EXCLUSION CRITERIA:

IQ< 70

Active psychosis

Any clinical condition in need of immediate care

Any chronic medical illness resulting in impaired CNS function

Any condition that would interfere with the participants ability to perform behavioral research tasks

Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.

Amish Community healthy volunteer children & adolescents:

INCLUSION CRITERIA:

Age 8-17

No serious physical or neurological symptoms or disorder by history

EXCLUSION CRITERIA:

I.Q. < 70

Ongoing medical illness

Neurological disorder (including seizures)

Past or present substance abuse

History of sexual abuse

Limitations with English that would interfere with understanding consent/assent, interview or task instructions

Past or present psychopathology in control subject or their first-degree relative

Amish Community adults who are parents of healthy volunteer children & adolescents, healthy spouses of Amish adults with BD, or parents of adolescents with BD:

INCLUSION CRITERIA:

Age 18-58

No serious physical or neurological symptoms or disorder by history

For Parents of child with BD or spouses of patient with BD: Spouse or offspring with BD

EXCLUSION CRITERIA:

I.Q. < 70

Ongoing medical illness

Neurological disorder (including seizures)

Past or present substance abuse

History of sexual abuse

Limitations with English that would interfere with understanding consent/assent, interview or task instructions

For Healthy volunteers: Past or present psychopathology in participant or their first-degree relative

For Parents of healthy volunteer children: Past or present psychopathology as in (4) above.

In addition, children with BD (Section B.1.) who wish to receive treatment, including discontinuation of medication while inpatients on the pediatric behavioral health unit at NIH, may be eligible for treatment if they meet the following additional criteria:

All inclusion criteria for B.1 (above)

Treatment failure as defined by current CGAS score < 60

The child s psychiatrist/treating physician agrees that a change in medication regimen is appropriate

EXCLUSION CRITERIA:

All exclusion criteria for B.1 (above)

Any contraindications for MRI scanning, plus claustrophobia or extreme separation anxiety

Both
3 Years to 17 Years
Yes
Contact: Ellen Leibenluft, M.D. (301) 496-9435 leibs@mail.nih.gov
United States
 
NCT00006177
000198, 00-M-0198
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National Institute of Mental Health (NIMH)
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Principal Investigator: Ellen Leibenluft, M.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP