Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder
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|ClinicalTrials.gov Identifier: NCT03901859|
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : May 3, 2019
|Condition or disease|
|Attention Deficit Hyperactivity Disorder|
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||A Study on the Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Patients with ADHD
drug-naive patients with ADHD, aged 7-18 year old
drug-naive healthy controls, aged 7-18 year old
- Serum level of Indolepropionic acid [IPA] [ Time Frame: 1 year ]tryptophan metabolite
- Serum level of indoleacetic acid [IAA] [ Time Frame: 1 year ]tryptophan metabolite
- Serum level of kynurenic acid [KYNA] [ Time Frame: 1 year ]tryptophan metabolite
- ADHD Rating Scale-IV [ Time Frame: 1 year ]behavioral measures
- Swanson, Nolan, and Pelham IV scale [ Time Frame: 1 year ]The SNAP-IV is a 26-items scale, consisting of the DSM-IV symptoms for the Inattention (Item 1-9) and the Hyperactivity/Impulsivity domains (Item 10-18) of the criteria for ADHD, and the oppositional symptoms (Item 19-26) of the criteria for ODD (20). As in the DSM-IV criteria, to describe psychopathology, the word "often" is included at the beginning of each item, so the precise interpretation of the 4-point rating scale (0 = "not at all", 2 = "just a little", 3 = "quite a bit", and 4 = "very much") reflects the degree that the behavior is abnormally frequent and severe compared to normal childhood behavior.
- Achenbach Child Behavior Checklist [ Time Frame: 1 year ]designed to assess the competencies and behavioral/emotional problems in children 4-18 for CBCL. rate how true each item is at present or within the last 6 months, using a 3-point response scale. subdivided into a profile report on child's standing in competence items and in 112 problem items. Internalizing score is composed of scores for anxiety/depression, somatic complaints, and withdrawal. Externalizing score is comprised of scores for delinquent behavior and aggressive behavior.
- Clinical Global Impressions-ADHD-Severity [ Time Frame: 1 year ]The CGI-ADHD-S (120) is a single item clinician rating of the assessment of the global severity of the ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill patients). The CGI-ADHD-S will be administered on each visit, from visit 1 through visit 10.
- Social Adjustment Inventory for Children and Adolescents [ Time Frame: 1 year ]The SAICA is a 77-item semi-structured interview scale that was designed for administration to school-aged children aged 6-18 about themselves, or to their parents about their children (121). The SAICA provides an evaluation of children's current functioning in the domains of (1) school, (2) spare time, (3) peer relations, and (4) home behaviors. A higher mean score (items rated on 4-point Likert scale from 1 to 4) indicates either poorer social function or a more severe social problem (121). (We delete the Spare time relationship in the Overall relationship) The score for each item ranges from 1 to 4. An increased score indicates either a decreased social function or an increased severity of social problem.
- Chinese version of the Family Adaptation, Partnership, Growth, Affection, and Resolve [ Time Frame: 1 year ]behavioral measures
- Cambridge Neuropsychological Test Automated Batteries [ Time Frame: 1 year ]neuropsychological measures
- Continuous Performance Test [ Time Frame: 1 year ]neuropsychological measures
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901859
|Contact: Chi-Yung Shang||02-23123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 110|
|Contact: Chi-Yung Shang, MDPHD 02-23123456 ext 66965 firstname.lastname@example.org|
|Principal Investigator:||Chi-Yung Shang, MDPHD||Dept of Psychiatry, National Taiwan University Hospital|