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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03901859
Collaborator
(none)
240
1
12
20

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Study on the Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder
    Actual Study Start Date :
    Apr 1, 2019
    Anticipated Primary Completion Date :
    Mar 31, 2020
    Anticipated Study Completion Date :
    Mar 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with ADHD

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

    Healthy Controls

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

    Outcome Measures

    Primary Outcome Measures

    1. Serum level of Indolepropionic acid [IPA] [1 year]

      tryptophan metabolite

    2. Serum level of indoleacetic acid [IAA] [1 year]

      tryptophan metabolite

    3. Serum level of kynurenic acid [KYNA] [1 year]

      tryptophan metabolite

    Secondary Outcome Measures

    1. ADHD Rating Scale-IV [1 year]

      behavioral measures

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. Chinese version of the Family Adaptation, Partnership, Growth, Affection, and Resolve [1 year]

      behavioral measures

    7. Cambridge Neuropsychological Test Automated Batteries [1 year]

      neuropsychological measures

    8. Continuous Performance Test [1 year]

      neuropsychological measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    The ADHD group

    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.

    1. Patients must be psychotropic drug-naïve. Patients will be considered to be drug-naïve if they have never received medications specifically to treat ADHD.

    2. Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.

    3. 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.

    4. 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.

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 110

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Chi-Yung Shang, MDPHD, Dept of Psychiatry, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03901859
    Other Study ID Numbers:
    • 201809043RINA
    First Posted:
    Apr 3, 2019
    Last Update Posted:
    May 3, 2019
    Last Verified:
    Nov 1, 2018
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2019