NIH Clinical Research Studies

Protocol Number: 00-M-0198

Active Accrual, Protocols Recruiting New Patients

Title:
The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents with Bipolar Disorder
Number:
00-M-0198
Summary:
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)

Sponsoring Institute:
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA - Bipolar patients:

Boys and girls must be ages 6-17 and meet DSM-IV criteria for bipolar disorder.

The child must have a primary caregiver who can accompany him or her on trips to NIMH, provide reliable history information, and complete daily rating scales and sleep logs.

Patients must have a psychiatrist who provides clinical care for their BPD.

All youth accepted into the study must be able to complete self-rating forms and to cooperate with other study procedures.

Subjects must be on a stable medication regimen for at least 14 days prior to enrollment in the study. In addition, they, their parents, and treating physician must agree to keep medications stable (with the exception of minor dosage adjustments) until the end of the second NIMH evaluation, if clinically feasible and acceptable. The total duration of the medication-stable period will be approximately six weeks.

INCLUSION CRITERIA - Controls:

Control subjects will be age- and sex-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.

INCLUSION CRITERIA - Children with ADHD:

Children with ADHD will be: age 7-17, currently meets DSM-IV criteria for ADHD (this will be determined by a K-SADS interview), t score greater than 65 on the Connors Parent scales, and in treatment for the illness with a physician.

INCLUSION CRITERIA - Children with BPD for Discontinuation of Medication with fMRI:

Individuals will meet criteria for BPD, as above. The criteria for treatment failure will be: 1) the child's current CGAS score is less than or equal to 60, and 2) the child's psychiatrist agrees that a change in medication regimen is justified clinically.

INCLUSION CRITERIA - Children at Risk for BPD:

Children age 3-17 with a parent or a sibling diagnosed with BPD.

EXCLUSION CRITERIA - Bipolar Patients:

I.Q. less than 70;

autistic disorder or severe pervasive developmental 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 bipolar illness (e.g. multiple sclerosis, thyroid disease).

Pregnancy.

Substance abuse within two months of the initial evaluation.

EXCLUSION CRITERIA - Controls:

I.Q. less than 70.

Ongoing medical illness.

Neurological disorder (including seizures).

Pregnancy.

Past or present substance abuse.

History of sexual abuse.

EXCLUSION CRITERIA - Children with ADHD:

Exclusion criteria will be IQ less than 80; pregnancy; ongoing medical illness or neurological disorder other than ADHD; contraindication to discontinuing medication for 48 hours; contraindication to fMRI scanning; any other psychiatric disorder that is sufficiently severe to require specific treatment, with the exception of oppositional defiant disorder, and the learning, communication, and elimination disorders.

EXCLUSION CRITERIA - Discontinuation of Medication with fMRI:

In addition to exclusion criteria for Bipolar patients, the presence of dental braces or extreme separation anxiety.

Special Instructions:
Protocol is currently recruiting bipolar patients who are not doing well on their current medication(s)
Keywords:
Emotion
Children and Adolescents
Affective Neuroscience
Bipolar Disorder
Child
Child Bipolar
Recruitment Keywords:
Child Bipolar
Bipolar Disorder
BPD
Adolescent Bipolar
Conditions:
Healthy
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Complex and rapid-cycling in bipolar children and adolescents: a preliminary study

Mania-like symptoms suggestive of childhood-onset bipolar disorder in clinically referred children

Pediatric-onset bipolar disorder: a neglected clinical and public health problem

Active Accrual, Protocols Recruiting New Patients

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