Genetic, Brain Structure, and Environmental Effects on ADHD

NCT01721720 | Completed

• 2 other identifiers: 12020212-HG-0202
• Study Type: observational
• Target: 1,091
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Attention deficit hyperactivity disorder (ADHD) is one of the most common and inheritable of all neuropsychiatric disorders. It causes problems with attention and impulse control. However, the genetic component of ADHD has not been fully studied, including how genes interact with the environment. Researchers want to study children and adults who have ADHD. They will look at how genetic, brain structure, and environmental factors affect ADHD in children and adults. Objectives: \- To study genetic, brain structure, and environmental factors in ADHD in children and adults. Eligibility: \- Individuals at least 3 years of age who have ADHD. Design:

• Participants will be screened with a physical exam and medical history.
• Participants will be interviewed about their ADHD. They will also complete behavior and psychological tests. Parents or guardians will complete the tests along with participants under 18 years of age.
• Participants will provide saliva or blood samples.
• Participants will also have imaging studies of the brain.
• Participants under 25 years of age will return once a year to repeat the tests. Those over 25 years of age will have only the one set of tests. Those who are starting stimulant drugs and who are receiving behavioral treatment for the first time will also have another set of tests 12 weeks after the start of treatment.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Peer and Family Networks; Longitudinal Outcome; MRI Imaging; Genetics; Childhood Psychiatric Disorders; Natural History

Outcome Measures

Primary Outcomes (1)

• Brain MRI

  Trajectories of brain development

  yearly or at the participant's availability

Secondary Outcomes (1)

• DNA collection, clinical interviews, social network information gathering

  yearly or at the participant's convenience

Study Arms (1)

Participants with and without ADHD

Participants with and without ADHD

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children, adolescents, and adults with Attention Deficit Hyperactivity Disorder and healthy controls. Some participants will be from families that have many individuals affected by ADHD.

You may qualify if:

• Three or more years of age with no upper limit for age at time of enrollment. The lower limit of 3 years of age is chosen as it is difficult to diagnose ADHD below this age, but the diagnosis can be reliably made from age 3 onwards. As this study examines the developmental trajectories of ADHD into adulthood, no upper age limit has been set.
• Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) defined ADHD. The DSM-IV diagnosis of ADHD will be based on the Parent Diagnostic Interview for Children and Adolescents in participants 18 years or age and younger and the
• Structured clinical interview for the Diagnosis of DSM Disorders for participants above 18 years of age. We include all forms of ADHD in DSM-5 (i.e. combined, predominately hyperactive/impulsive, predominately inattentive and other specified presentations). ADHD is rarely found in isolation and comorbidity is common. Thus the protocol will include individuals with ADHD and the
• following disorders: oppositional defiant disorder, conduct disorder, anxiety disorders (generalized anxiety, specific phobias), tic disorders, mood disorders (dysthymia, depression); specific learning disabilities and disruptive mood dysregulation disorder.
• In studying the acute effects of treatment we will include all participants with ADHD who are starting psychostimulant medications for the first time (all psychostimulant preparations are included). We will also include participants with ADHD who are receiving behavioral
• management for ADHD for the first time.
• We have already identified families of our currently enrolled probands in which at least 4 other first, second or third degree relatives have a current diagnosis of ADHD or had this diagnosis in childhood (and have a similar number of unaffected relatives). We will recruit further families with a similar density of individual affected by ADHD.

You may not qualify if:

• Full scale IQ of less than 70. Below this level a child is considered to have global intellectual disability (classified in DSM-IVR as mental retardation). By definition this means the individual cannot be considered to be a healthy control . While many individual with IQ below 70 have symptoms of ADHD, the diagnosis is complicated by problems in assessing attentional abilities.
• Finally, there are often issues around the ability to give informed consent in adults with global intellectual disability.
• Birth before 32 weeks of gestation. Premature birth can have a profound effect on brain function and structure.
• not however be included in GWAS due to analytic complications.
• Dental braces (as these distort the MRI image). Metal in the body or other contraindications for MRI scanning. For females who have reached menarche and have not yet past menopause: pregnancy or inability or unwillingness to undergo pregnancy testing (for MRI
• safety).
• For participants 60 years or older. Folstein mini mental state examination score of 26 or greater. This is a widely accepted screening test for dementia.
• Some neuropsychiatric disorders are either so rare or associated with such profound alterations of brains structure and function that they will be excluded. This includes psychotic disorders (including schizophrenia, psychosis NOS) bipolar affective disorder; autism, substance dependence; dementia.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Sudre G, Norman L, Bouyssi-Kobar M, Price J, Shastri GG, Shaw P. A Mega-analytic Study of White Matter Microstructural Differences Across 5 Cohorts of Youths With Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry. 2023 Jul 1;94(1):18-28. doi: 10.1016/j.biopsych.2022.09.021. Epub 2022 Sep 26.

  PMID: 36609028 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders

Study Officials

• Wallace P Shaw, M.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: November 9, 2012
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The timeline for data sharing will follow the NHGRI Genomic Data Sharing Policy. Currently data is deposited following IRB review once the study data collection is complete and the data has undergone quality control steps.
• Access Criteria: Access requests for specific research purposes using NIH controlled-access data are reviewed by NIH Data Access Committees (DACs).

Locations

US (1)