Adult Outcome of Children With Attention-deficit/Hyperactivity Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01247610
First received: November 22, 2010
Last updated: November 14, 2012
Last verified: January 2012
  Purpose

Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%), early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high heritability. Due to its lifelong impairments up to adulthood, adult ADHD has drawn much more attention in Western studies in the past decade; however, there has been no such study in Asian countries. The ultimate goals of this longitudinal follow-up study are to investigate the outcomes of a cohort of children with attention-deficit/hyperactivity (ADHD) and their healthy controls at young adulthood as the primary aim; and to test whether structural and functional brain connectivity can be endophenotypes of ADHD, to localize the brain area that are corresponding to methylphenidate treatment effects, and to identify the genetic variants corresponding to the persistence of ADHD, treatment effect of methylphenidate, neurocognitive dysfunction, and structural and functional dysconnectivity in the brain as the secondary aims. With the accomplishment of these goals, this study will provide the first-hand data on adult ADHD in non-western countries, and will be one of few world-class studies on the topics of neurocognitive and imaging genomics on adult ADHD.


Condition
Attention Deficit Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Adult Outcome of Children With Attention-deficit/Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

The subjects will receive blood withdrawal. The blood sample will be used for establishing lymphoblastoid cell lines, which will be used for molecular genetic experiments.


Estimated Enrollment: 390
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Groups/Cohorts
ADHD group
Control group

Detailed Description:

Primary specific aim:

To describe the manifestation and persistence of ADHD symptoms and to investigate the psychiatric, social, and executive functioning outcomes at young adulthood among children with ADHD;

Secondary specific aims

  1. To identify early individual (clinical, behavioral, and executive functioning and other neurocognitive variables), family, school, environmental factors to predict the symptom persistence and a wide-range of outcomes at young adulthood;
  2. To validate structural and functional connectivity of frontostriatal circuitry as imaging endophenotypes of ADHD by demonstrating that structural connectivity and functional connectivity of frontostriatal circuitry are altered in patients with ADHD and their unaffected siblings, are associated with ADHD symptoms, and are associated with genes related to dopamine neurotransmitter system;
  3. To identify brain area that is corresponding to the effect of methylphenidate; and
  4. To confirm reported candidate genes related to dopamine and noradrenergic neurotransmitter systems in the association with ADHD severity and subtypes (persistence, comorbidity, functional impairment, and treatment effects) and endophenotypes (executive function and structural and functional brain connectivity) such as DAT1, DRD4, MAO-A, ADRA2A, ADRA2C, NET, and COMT.

The sample consists of a cohort of 217 young adults (180 males, 83%) who were diagnosed of ADHD at childhood and 173 healthy controls (123 males, 71%). At their ages of 17-24 (around 6 years after their assessments at adolescence), they will receive psychiatric interviews (ADHD+SADS, CAADID) to make the diagnosis of ADHD and other psychiatric disorders and blood sample collection. They will complete the following questionnaires: ASRS and CAARS-S:S for adult ADHD symptoms, TPQ for personality characteristics, ASRI-4 for DSM-IV psychopathology, AAQoL and WFIRS for social functions, and PBI for parenting styles; and perform the WAIS-III for current IQ and Cambridge Neuropsychological Test Automated Batteries for attention control and executive functioning. Among the cohort subjects, 30 subjects with persistent ADHD and their same-sex and -handedness unaffected siblings (n = 30), 30 ADHD subjects who have DAT1 and/or good response to methylphenidate (repeated MRI assessment one week later) based on clinical assessment, and 30 subjects without lifetime ADHD and any psychiatric disorder will receive diffusion spectrum imaging (DSI) and resting state functional MRI assessments (total number of MRI assessments, 150). We will genotype 3'VNTR of DAT1 gene and other candidate genes involving dopaminergic and adrenergic systems (DRD4, MAO-A, ADRA2A, ADRA2C, NET, and COMT) for case-control association studies by using SNP and haplotype analysis.

We anticipate that this study (1) will provide the first prospective, longitudinal data of children with ADHD at late adolescence and young adulthood in Asian populations; (2) will be one of the first to establish a comprehensive, multi-dimensional dataset combining clinical, family, psychosocial, academic/vocational, neuropsychological, neuroimaging, and genetic data of young adults with ADHD. With the inclusion of imaging genetics data, the behavioral and neurocognitive phenotypes of ADHD can be validated, the imaging endophenotype can be tested, and image genetics approach may help identify genetic variants for ADHD.

  Eligibility

Ages Eligible for Study:   17 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The sample will consist of (1) 217 adolescents (180 males, 83%) who were diagnosed of ADHD at childhood and followed up by Gau and consented to this follow-up study, and (2) 173 healthy controls (123, Males, 71%) without lifetime ADHD to late adolescence and adulthood. This cohort was established from 2005 to 2008. We will invite them for complete assessments 6 years after their assessments at adolescence according to the original assessment schedules from 2005-2008. The estimated age ranges are 17-24 years old.

Criteria

Inclusion Criteria:

  1. Persistent ADHD combined type (Group 1, n=30): Subjects who have persistent diagnosis of ADHD, combined type, at adulthood according to the DSM-IV diagnostic criteria and who have same-sex unaffected siblings are included. If more than 30 subjects meet the inclusion criteria, the subjects with more severe ADHD symptoms based on the ASRS and K-SADS ratings will be included.
  2. Unaffected sibling (Group 2, n=30): The same sex and handedness unaffected siblings of Group 1 will be recruited. They need to be re-assessed by psychiatric interview to confirm no lifetime diagnosis of ADHD.
  3. Good response to MPH (Group 3, n=30): Subjects whose ADHD symptoms meet the DSM-IV symptom criteria at adulthood and who either have DAT1 genes (around 10% of Taiwanese children with ADHD15) or demonstrate good response to MPH based on clinical interview were recruited for offand on-stimulant DSI and resting state fMRI assessments.
  4. Non-ADHD (Group 4, n=30): Among healthy controls without lifetime ADHD, the controls who do not have any lifetime psychiatric disorders and who do not have impaired neuropsychological function will be included. The control subjects will be matched for the age, gender, and handedness of Group 1.

Exclusion Criteria:

  • These subjects will be excluded from the study if they have any of the following criteria: (1) Comorbidity with DSM-IV-TR diagnosis of pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy; and (3)With visual or hearing impairments, or motor disability which may influence the process of MRI assessment. In addition, if the control subjects have ODD or CD, they will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247610

Contacts
Contact: Susan Shur-Fen Gau, MD, PhD +886-2-23123456 ext 66802 gaushufe@ntu.edu.tw

Locations
Taiwan
National Taiwan Univeristy Hospital Recruiting
Taipei, Taiwan
Contact: Susan Shur-Fen Gau, MD, PhD    +886-2-23123456 ext 66802    gaushufe@ntu.edu.tw   
Principal Investigator: Susan Shur-Fen Gau, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Susan Shur-Fen Gau, MD, PhD National Taiwan University Hospital & College of Medicine
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01247610     History of Changes
Other Study ID Numbers: 201003087R
Study First Received: November 22, 2010
Last Updated: November 14, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014