Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
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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 |
Eligibility| Ages Eligible for Study: | 3 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- 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
Contacts and Locations| Contact: Ellen Leibenluft, M.D. | (301) 496-9435 | leibs@mail.nih.gov |
| 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 | |
| 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: | December 19, 2012 |
| 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 May 16, 2013