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Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Study NCT00001206.   Last updated on September 19, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)
Official Title  Biological Markers in Childhood Psychiatric Disorders
Brief Summary

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.

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.
Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Attention Deficit and Disruptive Behavior Disorder
Attention Deficit Disorder With Hyperactivity
Intervention 
MEDLINE PMIDs 8722742,   8540892,   9118321
Links NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  962
Start Date  June 1985
Completion Date
Eligibility 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).

Gender Both
Ages 6 Years to 17 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001206
Organization ID 850115
Secondary IDs †† 85-M-0115
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date May 2008
First Received Date  November 3, 1999
Last Updated Date September 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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