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Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)
This study has been completed.
First Received: November 3, 1999   Last Updated: June 17, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001206
  Purpose

The purpose of this study is to evaluate individuals with Attention Deficit/Hyperactivity Disorder (ADHD) to learn more about the genetics of the disease.

This study is part of other ongoing studies of individuals with ADHD. The study participants have already undergone neurobiological measurements, particularly magnetic resonance imaging (MRI) of the brain, through other research studies. As a follow-up to these studies, participants will next undergo psychiatric interviews, neuropsychological tests, and another MRI. In addition to the clinical evaluation of the participants, further research will be conducted on the genetics of ADHD. These genetic studies will evaluate people with ADHD as well as their family members and a control group of healthy people.


Condition
Attention Deficit and Disruptive Behavior Disorder
Attention Deficit Disorder With Hyperactivity

Study Type: Observational
Official Title: Biological Markers in Childhood Psychiatric Disorders

Resource links provided by NLM:


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

Estimated Enrollment: 962
Study Start Date: June 1985
Detailed Description:
  1. This protocol allows the continuing prospective longitudinal study of ADHD probands for whom we have neurobiological measures, particularly quantitative brain MRI. The follow-up consists of structured psychiatric interviews, and neuropsychological tests. Repeat MRI scans are obtained through protocol 89-M-0006.
  2. The second purpose of this protocol is a study of the genetics of Attention-Deficit/Hyperactivity Disorder (ADHD). Subjects who have ADHD, their family members, and controls are studied under this protocol.
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION REQUIREMENTS-PROBANDS:

Current age of index probands: 15.21 plus or minus 3.42; previous participation in the NIMH Child Psychiatry Branch ADHD study.

Age adjusted dimensional ratings (Connor Rating Scales-Revised, and Strengths and Weaknesses of ADHD and Normal Behavior (SWAN)) of hyperactivity/impulsivity greater than or equal to 95th percentile for index and second sibling. Primary ratings for the index proband will be provided by main teacher.

Up to 150 ADHD probands for reassessment.

Consent and assent obtained in writing.

EXCLUSION CRITERIA - PROBANDS:

Presence of other known genetic conditions that are likely to be etiologic.

Onset of medical conditions that could produce symptoms of ADHD through non-genetic mechanisms (e.g., thyroid disorders, seizure disorders, inborn errors of metabolism, extremely low birth weight (less than 1000 gm), meningitis, intracranial pathology).

Presence of other psychiatric disorders that can produce symptoms similar to ADHD (e.g., major depression, bipolar disorder, severe anxiety disorders, pervasive developmental disorders, psychotic disorders, post-traumatic stress disorder).

Presence of neuropsychiatric conditions that may confound evaluation of ADHD (e.g., Tourette's syndrome, obsessive-compulsive disorder, or PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcus), intelligence quotient less than 80, reading achievement standard scores less than 75 or reading-intelligence discrepancy greater than 2 SD).

INCLUSION REQUIRMENTS-RELATIVES:

Subjects must be relatives of probands.

Consent and assent obtained in writing.

INCLUSION REQUIREMENTS -NORMAL VOLUNTEERS:

Up to 150 newly accrued normal volunteers unrelated to probands.

Same age range as probands.

Parent and teacher ratings within one SD of population means on ADHD/hyperactivity factors.

Consent and assent obtained in writing.

EXCLUSIONS - NORMAL VOLUNTEERS:

Presence of ADHD.

Presence of any psychiatric disorders on structured psychiatric interview (DICA-IV).

Presence of known genetic conditions.

Onset, presence or history of medical conditions that could produce symptoms of ADHD through non-genetic mechanisms (e.g., thyroid disorders, seizure disorders, inborn errors of metabolism, extremely low birth weight (less than 1000 gm), meningitis, intracranial pathology).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001206

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 850115, 85-M-0115
Study First Received: November 3, 1999
Last Updated: June 17, 2009
ClinicalTrials.gov Identifier: NCT00001206     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Attention Deficit Hyperactivity Disorder
Disruptive Behavior Disorders
Cerebrospinal Fluid
Lumbar Puncture
CSF
Longitudinal Prospective Follow-Up
Psychosocial Functioning
Risk Factors
Genetics

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Signs and Symptoms
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias

ClinicalTrials.gov processed this record on July 02, 2009