Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study

This study is currently recruiting participants. (see Contacts and Locations)
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: June 28, 2014
Last verified: September 2013
  Purpose

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)


Condition
Healthy
Bipolar Disorder

Study Type: Observational
Official Title: The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents With Bipolar Disorder

Resource links provided by NLM:


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

Estimated Enrollment: 2200
Study Start Date: August 2000
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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 or SMIBRD:

INCLUSION CRITERIA:

Age 6-17

Meet DSM 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 BSD.

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 BSD (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 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.

Have an identified primary care physician.

Speaks English

EXCLUSION CRITERIA

I.Q. < 70

Any serious medical condition or condition that interferes with fMRI scanning

Pregnancy

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.

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

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

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

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.

A parent or sibling with a history of a 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

  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: NCT00006177

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: NCT00006177     History of Changes
Other Study ID Numbers: 000198, 00-M-0198
Study First Received: August 12, 2000
Last Updated: June 28, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Emotion
Children and Adolescents
Affective Neuroscience
Bipolar Disorder
Child
Child Bipolar
BPD
Adolescent Bipolar

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

ClinicalTrials.gov processed this record on July 22, 2014