- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00916851
Clinical, Environmental, Neurocognitive, Brain Imaging, and Genetic Validity of Autism and ADHD
Clinical, Environmental, Neurocognitive, Brain Imaging, and Genetic Validity of Autism and Attention-deficit Hyperactivity Disorder
Study Overview
Status
Detailed Description
Specific Aims:
- To compare the individual phenotypes (emotion/behaviors, attention, impulsivity, etc.), endophenotypes (neurocognitive and social cognitive function, brain imaging), and genotypes, and growing environments (prenatal and developmental history, family, school, and social functions) among ASD, ADHD, and normal children to search for etiologies and developmental psychopathologies for ASD and ADHD and to test the discriminative validity of /between ASD and ADHD; and
- To examine whether the correlations and interactions among/within behavioral phenotypes, endophenotypes, genotypes, and environments vary across the three groups.
This 3-year program project consists of three projects investigating a sample, aged 8-17 years, of 100ASD, 100ADHD, and 100 normally developing children and adolescents.
- Using diagnostic interviews, observation, self-administered questionnaires, social cognitive tests (emotion recognition test, mentalizing test) and neurocognitive tests (CANTAB, CPT, WCST, WISC-III-R, Émbedded Figure Test, Global-local Perception Test), we will collect data from 300 subjects (100 for each group) regarding individual (phenotype & endophenotype) and growing environments.
- Using Diffusion Spectrum Imaging, resting-state functional MRI (fMRI), cognitive fMRI (fMRI- semantic association test, fMRI-stroop test), and template, we will collect brain imaging data from 90 subjects regarding individual endophenotype.
- We will collect the blood samples to establish the cell lines and to conduct SNP genotyping, haplotype, and copy number variation analysis.
With accomplishment of this project, we will not only establish the genotypes for phenotype and endophenotype of general characteristics and assist identifying pathogenesis of ASD and ADHD, but also contribute the etiological studies on several adult psychiatric disorders in future prospective follow-up of this cohort.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taipei, Taiwan
- National Taiwan Univeristy Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Control group: Subjects without ADHD or ASD; ADHD group & ASD group: subjects have a clinical diagnosis of ADHD, or ASD defined by the DSM-IV, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits.
- Ages range from 7 to 18 when we conduct the study.
- Subjects have at least one biological parent.
- Both parents are Han Chinese.
- subjects and their biological parents (and siblings if any) consent to participate in this study for complete phenotype assessments and blood withdraw for genetic study
Exclusion Criteria:
- The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, Mental Retardation, or Pervasive Developmental Disorder. Moreover, the subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD or ASD in addition to the above exclusion criteria.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control group
Normally developing children and adolescents
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ADHD group
Children and adolescents with ADHD
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ASD group
Children and adolescents with ASD
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Collaborators and Investigators
Publications and helpful links
General Publications
- Chiang HL, Chen YJ, Shang CY, Tseng WY, Gau SS. Different neural substrates for executive functions in youths with ADHD: a diffusion spectrum imaging tractography study. Psychol Med. 2016 Apr;46(6):1225-38. doi: 10.1017/S0033291715002767. Epub 2016 Jan 8.
- Chiang HL, Chen YJ, Lo YC, Tseng WY, Gau SS. Altered white matter tract property related to impaired focused attention, sustained attention, cognitive impulsivity and vigilance in attention-deficit/ hyperactivity disorder. J Psychiatry Neurosci. 2015 Sep;40(5):325-35. doi: 10.1503/jpn.140106.
- Tsai CJ, Lin HY, Tseng IW, Gau SS. White matter microstructural integrity correlates of emotion dysregulation in children with ADHD: A diffusion imaging tractography study. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Aug 30;110:110325. doi: 10.1016/j.pnpbp.2021.110325. Epub 2021 Apr 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Disease
- Attention Deficit Disorder with Hyperactivity
- Autistic Disorder
- Autism Spectrum Disorder
- Hyperkinesis
Other Study ID Numbers
- 200903062R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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