ClinicalTrials.gov

History of Changes for Study: NCT01721720
Genetic, Brain Structure, and Environmental Effects on ADHD
Latest version (submitted June 13, 2024) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 November 2, 2012 None (earliest Version on record)
2 December 15, 2012 Study Status
3 December 19, 2012 Study Status
4 February 20, 2013 Contacts/Locations and Study Status
5 June 15, 2013 Study Status
6 November 27, 2013 Eligibility, Study Description and Study Status
7 February 14, 2014 Eligibility, Study Description and Study Status
8 February 19, 2014 Eligibility, Study Description and Study Status
9 March 14, 2014 Study Status
10 March 29, 2014 Eligibility and Study Status
11 June 25, 2014 Study Status
12 November 11, 2014 Sponsor/Collaborators and Study Status
13 January 27, 2015 Study Status
14 February 25, 2015 Study Design and Study Status
15 May 8, 2015 Study Design and Study Status
16 May 16, 2015 Study Status
17 March 1, 2016 Contacts/Locations and Study Status
18 March 22, 2016 Study Design and Study Status
19 March 25, 2016 Study Status
20 August 6, 2016 Eligibility and Study Status
21 August 31, 2016 References and Study Status
22 September 27, 2016 Study Status
23 January 19, 2017 Study Status and Study Design
24 January 20, 2017 Study Status
25 January 24, 2017 Study Status
26 March 10, 2017 Study Status
27 April 20, 2017 Study Status
28 June 30, 2017 Study Status
29 October 18, 2017 Study Status
30 December 27, 2017 Study Status
31 February 13, 2018 Study Status
32 March 27, 2018 Contacts/Locations and Study Status
33 April 18, 2018 Study Status
34 August 8, 2018 Oversight and Study Status
35 September 22, 2018 Study Design and Study Status
36 September 26, 2018 Study Status
37 November 29, 2018 Study Status, Eligibility, Study Design, Outcome Measures and Conditions
38 December 4, 2018 Study Status
39 December 5, 2019 Eligibility and Study Status
40 December 10, 2019 Study Status
41 December 19, 2019 Study Status
42 April 10, 2020 Groups and Interventions and Study Status
43 April 11, 2020 Eligibility and Study Status
44 April 16, 2020 Study Status
45 July 17, 2020 Study Status
46 August 13, 2020 References, Groups and Interventions and Study Status
47 August 15, 2020 Study Status
48 November 14, 2020 Study Status
49 December 19, 2020 Study Status
50 April 23, 2021 Study Status
51 May 11, 2021 Study Status
52 May 15, 2021 Study Status
53 June 12, 2021 Study Status
54 June 16, 2021 Study Status
55 June 23, 2021 Study Status
56 June 29, 2021 Study Status
57 July 22, 2021 Study Status
58 July 23, 2021 Study Status
59 October 15, 2021 Study Status
60 October 16, 2021 Study Status
61 October 21, 2021 Study Status
62 October 22, 2021 Study Status
63 October 23, 2021 Study Status
64 October 28, 2021 Study Status
65 October 30, 2021 Study Status
66 December 4, 2021 Study Status
67 December 9, 2021 Study Status
68 December 15, 2021 Conditions and Study Status
69 January 25, 2022 Study Status
70 January 26, 2022 Study Status
71 February 26, 2022 Study Status
72 March 1, 2022 Study Status
73 March 9, 2022 Study Status
74 March 11, 2022 Study Status
75 March 15, 2022 Study Status
76 March 16, 2022 Study Status
77 March 17, 2022 Study Status
78 March 18, 2022 Study Status
79 March 19, 2022 Study Status
80 March 22, 2022 Study Status
81 March 23, 2022 Study Status
82 March 24, 2022 Study Status
83 March 25, 2022 Study Status
84 March 26, 2022 Study Status
85 March 30, 2022 Study Status
86 March 31, 2022 Study Status
87 April 1, 2022 Study Status
88 April 2, 2022 Study Status
89 April 5, 2022 Study Status
90 April 6, 2022 Study Status
91 April 7, 2022 Study Status
92 April 8, 2022 Study Status
93 April 9, 2022 Study Status
94 April 13, 2022 Study Status
95 April 14, 2022 Study Status
96 April 15, 2022 Study Status
97 April 16, 2022 Study Status
98 April 19, 2022 Study Status
99 April 20, 2022 Study Status
100 April 21, 2022 Study Status
101 April 22, 2022 Study Status
102 April 23, 2022 Study Status
103 April 26, 2022 Study Status
104 April 27, 2022 Study Status
105 April 29, 2022 Study Status
106 May 2, 2022 Study Status
107 May 3, 2022 Study Status
108 May 4, 2022 Study Status
109 May 5, 2022 Study Status
110 May 6, 2022 Study Status
111 May 9, 2022 Study Status
112 May 10, 2022 Study Status
113 May 11, 2022 Study Status
114 May 12, 2022 Study Status
115 May 13, 2022 Study Status
116 May 16, 2022 Study Status
117 May 17, 2022 Study Status
118 May 18, 2022 Study Status
119 May 19, 2022 Study Status
120 May 20, 2022 Study Status
121 May 23, 2022 Study Status
122 May 24, 2022 Study Status
123 May 25, 2022 Study Status
124 May 26, 2022 Study Status
125 May 27, 2022 Study Status
126 May 31, 2022 Study Status
127 June 1, 2022 Study Status
128 June 2, 2022 Study Status
129 June 3, 2022 Study Status
130 June 6, 2022 Study Status
131 June 7, 2022 Study Status
132 June 8, 2022 Study Status
133 June 9, 2022 Study Status
134 June 10, 2022 Study Status
135 June 13, 2022 Study Status
136 June 14, 2022 Study Status
137 June 15, 2022 Study Status
138 June 17, 2022 Study Status
139 June 21, 2022 Study Status
140 June 22, 2022 Study Status
141 June 23, 2022 Study Status
142 June 24, 2022 Study Status
143 June 27, 2022 Study Status
144 June 29, 2022 Study Status
145 June 30, 2022 Study Status
146 July 1, 2022 Study Status
147 July 5, 2022 Study Status
148 July 6, 2022 Study Status
149 July 9, 2022 Study Status
150 August 24, 2022 Study Status
151 August 31, 2022 Study Status
152 September 7, 2022 Contacts/Locations and Study Status
153 September 8, 2022 Study Status
154 September 16, 2022 Eligibility, Outcome Measures, Groups and Interventions, Oversight, Study Status and IPDSharing
155 October 13, 2022 Study Status
156 November 1, 2022 Study Status
157 November 3, 2022 Study Status
158 December 16, 2022 Study Status
159 December 17, 2022 Study Status
160 December 23, 2022 Study Status
161 December 28, 2022 Study Status
162 December 31, 2022 Study Status
163 January 4, 2023 Study Status
164 January 7, 2023 Study Status
165 January 12, 2023 Study Status
166 January 21, 2023 Study Status
167 January 25, 2023 Study Status
168 February 7, 2023 Study Status
169 February 9, 2023 Study Status
170 March 24, 2023 Study Status
171 March 29, 2023 Study Status
172 April 1, 2023 Study Status
173 April 7, 2023 Study Status
174 April 21, 2023 Study Status
175 May 4, 2023 Study Status
176 May 20, 2023 Study Status
177 May 24, 2023 Study Status
178 July 20, 2023 Study Status
179 July 22, 2023 Study Status
180 September 2, 2023 Recruitment Status, Study Status, Contacts/Locations, Study Design and References
181 September 22, 2023 Study Status
182 September 30, 2023 Study Status
183 December 13, 2023 Study Status
184 December 16, 2023 Study Status
185 December 23, 2023 Study Status
186 January 6, 2024 Study Status
187 January 13, 2024 Study Status
188 February 22, 2024 Study Status
189 February 23, 2024 Study Status
190 February 27, 2024 Study Status
191 February 29, 2024 Study Status
192 May 2, 2024 Study Status
193 May 3, 2024 Study Status
194 June 13, 2024 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT01721720
Submitted Date:  November 2, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 120202
Brief Title: Genetic, Brain Structure, and Environmental Effects on ADHD
Official Title: The Neurobehavioral, Environmental and Genetic Factors Impacting the Clinical Course of Attention Deficit Hyperactivity Disorder
Secondary IDs: 12-HG-0202
Open or close this module Study Status
Record Verification: August 2012
Overall Status: Recruiting
Study Start: September 2012
Primary Completion:
Study Completion:
First Submitted: November 2, 2012
First Submitted that
Met QC Criteria:
November 2, 2012
First Posted: November 6, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 2, 2012
Last Update Posted: November 6, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Human Genome Research Institute (NHGRI)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
Detailed Description:

OBJECTIVES:

This study aims to provide novel phenotypes for genomic studies into Attention- Deficit Hyperactivity Disorder (ADHD), one of the most common and heritable of all neuropsychiatric disorders. It proposes to split the disorder into neurobiologically more meaningful entities by delineating subgroups based on neurobehavioral profiles. It will also explore factors that impact clinical course, focusing on the neural effects of treatment and the role of the child's social environment.

POPULATION AND DESIGN:

Using a prospective longitudinal design, a group of children and adolescents with ADHD will be followed. Additionally, families that have several members affected by ADHD will be recruited.

OUTCOMES:

The study will link the onset and clinical course of ADHD with genotype, brain structure and function, behavior and the child's social environment.

Open or close this module Conditions
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Hyperactivity Disorder
Behavioral Phenotype
Brain Development
Complex Disease
Social Networks
Open or close this module Study Design
Study Type: Observational
Time Perspective:
Biospecimen Retention:
Biospecimen Description:
Enrollment: 870 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 3 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:
  • INCLUSION CRITERIA FOR ALL PARTICIPANTS:

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.

INCLUSION CRITERIA FOR CLINICAL POPULATIONS:

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 Schedule for the Diagnosis of DSM Disorders for participants above 18 years of age. For those of school age, an additional inclusion criterion is the Conners' Teacher Hyperactivity rating greater than 1.5 standard deviations above age- and sex-specific means. 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. 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.

INCLUSIONS CRITERIA FOR THE FAMILY STUDY:

We will also include families where there is a incidence of > 30% of ADHD in first, second and third degree relatives. This level is chosen as it is well above the incidence rate of ADHD in the general population (~5-7%). Additional inclusion criteria are families where the proband has at least one sibling and only one or neither parent is affected. 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.

EXCLUSION CRITERIA FOR ALL PARTICIPANTS:

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.

Presence or history of medical conditions that are known to cause alterations in cerebral anatomy detectable by neuroimaging that is current accepted clinical use. Examples include a history of stroke, arteriovenous malformations, agenesis of the corpus callosum, history of neurosurgery, hydrocephalus. Genetic syndromes which are associated with well established alterations of gross cerebral structure- such as NF1, tuberous sclerosis and some forms of epilepsy. Children with known microdeletion syndromes will not be excluded provided (1) the syndrome is not known to be associated with alteration of cerebral anatomy (detectable on current clinical MRI sequences) and (2) other exclusionary criteria do not apply - such as global intellectual impairment (defined in this protocol as IQ above 70). Data from these individuals with microdeletion syndromes will 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.

Females who are pregnant will not participate in the MRI scanning only. They will be able to participate in all other parts of the study and can complete the MRI scan post-partum. 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.

ADDITIONAL EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS ONLY: Presence of any DSM-IV

psychiatric disorder in the subject or current use of psychiatric medication.

ADDITIONAL EXCLUSION CRITERIA FOR THE CLINICAL POPULATION ONLY:

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.

Open or close this module Contacts/Locations
Central Contact Person: Wendy S Sharp, L.C.S.W.
Telephone: (301) 496-0851
Email: wsharp@helix.nih.gov
Central Contact Backup: Wallace P Shaw, M.D.
Telephone: (301) 402-8867
Email: shawp@mail.nih.gov
Study Officials: Wallace P Shaw, M.D.
Principal Investigator
National Human Genome Research Institute (NHGRI)
Locations: United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
[Recruiting]
Bethesda, Maryland, United States, 20892
Contact:Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 Ext. TTY8664111010 prpl@mail.cc.nih.gov
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Band GP, van Boxtel GJ. Inhibitory motor control in stop paradigms: review and reinterpretation of neural mechanisms. Acta Psychol (Amst). 1999 Apr;101(2-3):179-211. doi: 10.1016/s0001-6918(99)00005-0. PubMed 10344185
Arcos-Burgos M, Jain M, Acosta MT, Shively S, Stanescu H, Wallis D, Domene S, Velez JI, Karkera JD, Balog J, Berg K, Kleta R, Gahl WA, Roessler E, Long R, Lie J, Pineda D, Londono AC, Palacio JD, Arbelaez A, Lopera F, Elia J, Hakonarson H, Johansson S, Knappskog PM, Haavik J, Ribases M, Cormand B, Bayes M, Casas M, Ramos-Quiroga JA, Hervas A, Maher BS, Faraone SV, Seitz C, Freitag CM, Palmason H, Meyer J, Romanos M, Walitza S, Hemminger U, Warnke A, Romanos J, Renner T, Jacob C, Lesch KP, Swanson J, Vortmeyer A, Bailey-Wilson JE, Castellanos FX, Muenke M. A common variant of the latrophilin 3 gene, LPHN3, confers susceptibility to ADHD and predicts effectiveness of stimulant medication. Mol Psychiatry. 2010 Nov;15(11):1053-66. doi: 10.1038/mp.2010.6. Epub 2010 Feb 16. PubMed 20157310
Bagwell CL, Molina BS, Pelham WE Jr, Hoza B. Attention-deficit hyperactivity disorder and problems in peer relations: predictions from childhood to adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1285-92. doi: 10.1097/00004583-200111000-00008. PubMed 11699802
Links: Description: NIH Clinical Center Detailed Web Page
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services