Attention Deficit and Disruptive Behavior DisorderNCT00001206
Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)
An observational study of Attention Deficit and Disruptive Behavior Disorder and Attention Deficit Disorder With Hyperactivity, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit and Disruptive Behavior Disorder, Attention Deficit Disorder With Hyperactivity
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 1985to 15 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Subjects must be relatives of probands.
- Consent and assent obtained in writing.
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- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Biological Markers in Childhood Psychiatric Disorders
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.
Read the 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.
- Conditions
- 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
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Attention Deficit and Disruptive Behavior Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start5 Jun 1985
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit and Disruptive Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Judith L Rapoport, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001206
- Sponsor's protocol ID
- 850115
- Other IDs
- 85-M-0115
- Status last verified
- 15 May 2017
- First submitted
- 3 Nov 1999
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
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.
PubMed 8722742Thapar 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.
PubMed 8540892LaHoste 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.
PubMed 9118321
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Markers in Childhood Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT00001206
- Acronym / sponsor ID
- 850115
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 5 Jun 1985
- Study completion
- 15 May 2017
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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.
- Subjects must be relatives of probands.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 8722742Hauser 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.
- Background: PubMed 8540892Thapar 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.
- Background: PubMed 9118321LaHoste 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith L Rapoport, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit and Disruptive Behavior Disorder and Attention Deficit Disorder With Hyperactivity, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001206, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019; AzTrials last refreshed its copy on 31 Oct 2026.