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Status unknownNCT03901859Updated May 3, 2019

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

An observational study in Attention Deficit Hyperactivity Disorder, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 7 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-03.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
240
Ages
7 Years to 18 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • ADHD
  • tryptophan
  • executive function
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's planned enrollment of 240 is above the median of 134 across 122 observational studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

120 drug-naïve patients with ADHD, aged 7 to 18 years, will be enrolled. Another 120 healthy participants with matched age and sex will be enrolled in the control group.

The ADHD group

Inclusion criteria

  1. Inclusion Criteria

    Patients with ADHD are eligible to be included in this study only if they meet all of the following criteria:

    1. Patients will be outpatients who are between 7 and 18 years of age.
    2. Patients must have ADHD that meet the Diagnostic and Statistical Manual of Mental disorders, 5th edition (DSM-V) disease diagnostic criteria assessed by the investigator's clinical evaluation, as well as confirmed by the Chinese version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Epidemiological Version (K-SADS-E).
    3. Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score > 4 at baseline.
    4. Patients must be psychotropic drug-naïve. Patients will be considered to be drug-naïve if they have never received medications specifically to treat ADHD.
    5. Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.
    6. Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as achieving a score of 80 or more when IQ testing is administrated.
    7. Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including neuropsychological testing and venipunctures.

Exclusion criteria

Patients will be excluded from the study if they meet any of the following criteria:

  1. Patients with current or past history of schizophrenia, schizoaffective Disorder, organic psychosis, bipolar I or II disorder, autism, or autism spectrum disorder. Other comorbid psychiatric disorders are not excluded if the ADHD symptoms are the primary source of impairment for the patient.
  2. Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.
  3. Patients have been at serious suicidal risk, determined by the investigator.
  4. Patients with a history of alcohol or drug abuse within the past 3 months, or who are currently using alcohol, drugs of abuse, or any described or over-the-counter medication in a manner that the investigator considers indicative of abuse.
  5. Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
  6. Patients who are likely to need Chinese medicine or health-food supplements that have central nervous system activity.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
240 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with ADHD

    drug-naive patients with ADHD, aged 7-18 year old

  • Healthy Controls

    drug-naive healthy controls, aged 7-18 year old

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What researchers measure

Primary outcomes

  1. Serum level of Indolepropionic acid [IPA]

    tryptophan metabolite

    Time frame: 1 year

  2. Serum level of indoleacetic acid [IAA]

    tryptophan metabolite

    Time frame: 1 year

  3. Serum level of kynurenic acid [KYNA]

    tryptophan metabolite

    Time frame: 1 year

Secondary outcomes

  1. ADHD Rating Scale-IV

    behavioral measures

    Time frame: 1 year

  2. Swanson, Nolan, and Pelham IV scale

    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.

    Time frame: 1 year

  3. Achenbach Child Behavior Checklist

    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.

    Time frame: 1 year

  4. Clinical Global Impressions-ADHD-Severity

    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.

    Time frame: 1 year

  5. Social Adjustment Inventory for Children and Adolescents

    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.

    Time frame: 1 year

  6. Chinese version of the Family Adaptation, Partnership, Growth, Affection, and Resolve

    behavioral measures

    Time frame: 1 year

  7. Cambridge Neuropsychological Test Automated Batteries

    neuropsychological measures

    Time frame: 1 year

  8. Continuous Performance Test

    neuropsychological measures

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 110, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03901859
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Apr 3, 2019
Start date
Apr 1, 2019
Primary completion
Mar 31, 2020 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
May 3, 2019

Study contacts

Chi-Yung Shang
Contact
cyshang@ntu.edu.tw
02-23123456 ext. 66965
Chi-Yung Shang, MDPHD
principal investigator · Dept of Psychiatry, National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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