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Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)

Primary Purpose

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

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Attention Deficit and Disruptive Behavior Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Disruptive Behavior Disorders, Cerebrospinal Fluid, Lumbar Puncture, CSF, Longitudinal Prospective Follow-Up, Psychosocial Functioning, Risk Factors, Genetics

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 (Conners 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 other 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).

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
December 13, 2019
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00001206
Brief Title
Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)
Official Title
Biological Markers in Childhood Psychiatric Disorders
Study Type
Observational

2. Study Status

Record Verification Date
May 15, 2017
Overall Recruitment Status
Completed
Study Start Date
June 5, 1985 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 15, 2017 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit and Disruptive Behavior Disorder, Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Hyperactivity Disorder, Disruptive Behavior Disorders, Cerebrospinal Fluid, Lumbar Puncture, CSF, Longitudinal Prospective Follow-Up, Psychosocial Functioning, Risk Factors, Genetics

7. Study Design

Enrollment
347 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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 (Conners 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 other 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith L Rapoport, M.D.
Organizational Affiliation
National Institute of Mental Health (NIMH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8722742
Citation
Hauser ER, Boehnke M, Guo SW, Risch N. Affected-sib-pair interval mapping and exclusion for complex genetic traits: sampling considerations. Genet Epidemiol. 1996;13(2):117-37. doi: 10.1002/(SICI)1098-2272(1996)13:23.0.CO;2-5.
Results Reference
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PubMed Identifier
8540892
Citation
Thapar A, Hervas A, McGuffin P. Childhood hyperactivity scores are highly heritable and show sibling competition effects: twin study evidence. Behav Genet. 1995 Nov;25(6):537-44. doi: 10.1007/BF02327577.
Results Reference
background
PubMed Identifier
9118321
Citation
LaHoste GJ, Swanson JM, Wigal SB, Glabe C, Wigal T, King N, Kennedy JL. Dopamine D4 receptor gene polymorphism is associated with attention deficit hyperactivity disorder. Mol Psychiatry. 1996 May;1(2):121-4.
Results Reference
background

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Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)

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