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Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study

Sponsored by National Institutes of Health Clinical Center (CC)

Phase Quota
Phase N/A

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)

Study Start Date: August 2000

Estimated Completion Date: Not specified

Specialties: Pediatrics: Child/Adolescent Psych Psychiatry: Child/Adolescent Psych,Mood Disorders Radiology: MRI,Neuroradiology

Interventions

No interventions cited

Inclusion criteria

Pediatric patients with bipolar disorder:

  • 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.

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

  • 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

Healthy volunteer children and adolescents:

  • 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.

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

  • 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

Control subjects with ADHD but not BD:

  • 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

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

  • 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

Amish Community children with BD:

  • 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.

Amish Community Adults with BD:

  • DSM-IV Bipolar Disorder
  • Age 18-58
  • Be able to complete self-rating forms and to cooperate with other study procedures.

Amish Community at-risk subjects:

  • Age 8-17
  • Parent or sibling (first-degree relative) diagnosed with BD

Amish Community healthy volunteer children & adolescents:

  • Age 8-17
  • No serious physical or neurological symptoms or disorder by history

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

  • 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

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

Pediatric patients with bipolar disorder:

  • 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:

  • 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:

  • 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):

  • 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:

  • 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:

  • 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:

  • 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:

  • 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:

  • 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:

  • 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:

  • 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 exclusion criteria for B.1 (above)
  • Any contraindications for MRI scanning, plus claustrophobia or extreme separation anxiety

Study Locations And Contact Information

  • National Institutes of Health Clinical Center 9000 Rockville Pike, Bethesda Maryland
    Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office PRPL 800-411-1222 prpl@mail.cc.nih.gov
  • National Institutes of Health Clinical Center 9000 Rockville Pike, Bethesda Maryland

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