Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT03901859
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The present project is to identify the relationship between ADHD and the metabolites of tryptophan.

Detailed Description

Because attention deficit hyperactivity disorder (ADHD) is an early onset and long-term impairing disorder with tremendous impact on individuals, families, and societies, detection and diagnosis are very important for ADHD. According to investigators previous work, participants with ADHD have executive dysfunction. Previous studies show that tryptophan is associated with cognitive problems in participants. Analyzing differences in tryptophan metabolites (Indolepropionic acid \[IPA\], indoleacetic acid \[IAA\], and kynurenic acid \[KYNA\]) between participants with ADHD and healthy controls could provide insight into underlying disease pathology of cognitive deficits. In this one-year project, investigators will perform an analysis of tryptophan metabolites in serum to identify potential biomarkers for the executive dysfunction of ADHD.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2019-03-28
• Study Start: 2019-04-01
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum level of Indolepropionic acid [IPA]	1 year	tryptophan metabolite
Serum level of indoleacetic acid [IAA]	1 year	tryptophan metabolite
Serum level of kynurenic acid [KYNA]	1 year	tryptophan metabolite

Secondary Outcome Measures

Name	Time	Method
Swanson, Nolan, and Pelham IV scale	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.
Continuous Performance Test	1 year	neuropsychological measures
Social Adjustment Inventory for Children and Adolescents	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.
Cambridge Neuropsychological Test Automated Batteries	1 year	neuropsychological measures
Clinical Global Impressions-ADHD-Severity	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.
ADHD Rating Scale-IV	1 year	behavioral measures
Achenbach Child Behavior Checklist	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.
Chinese version of the Family Adaptation, Partnership, Growth, Affection, and Resolve	1 year	behavioral measures

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan