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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date March 28, 2019
First Posted Date April 3, 2019
Last Update Posted Date May 3, 2019
Actual Study Start Date April 1, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 15, 2019)
  • 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
Original Secondary Outcome Measures
 (submitted: April 2, 2019)
  • ADHD Rating Scale-IV [ Time Frame: 1 year ]
    behavioral measures
  • Swanson, Nolan, and Pelham IV scale [ Time Frame: 1 year ]
    behavioral measures
  • Achenbach Child Behavior Checklist [ Time Frame: 1 year ]
    behavioral measures
  • Clinical Global Impressions-ADHD-Severity [ Time Frame: 1 year ]
    behavioral measures
  • Social Adjustment Inventory for Children and Adolescents [ Time Frame: 1 year ]
    behavioral measures
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder
Official Title A Study on the Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
plasma
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.
Condition Attention Deficit Hyperactivity Disorder
Intervention Not Provided
Study Groups/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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 2, 2019)
240
Original Estimated Enrollment
 (submitted: April 2, 2019)
300
Estimated Study Completion Date March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
    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.
  2. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Chi-Yung Shang 02-23123456 ext 66965 cyshang@ntu.edu.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03901859
Other Study ID Numbers 201809043RINA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Chi-Yung Shang, MDPHD Dept of Psychiatry, National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date November 2018