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

NCT03901859 | Unknown

• 1 other identifier: 201809043RINA
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; tryptophan; executive function

Outcome Measures

Primary Outcomes (3)

• Serum level of Indolepropionic acid [IPA]

  tryptophan metabolite

  1 year

• Serum level of indoleacetic acid [IAA]

  tryptophan metabolite

  1 year

• Serum level of kynurenic acid [KYNA]

  tryptophan metabolite

  1 year

Secondary Outcomes (8)

• ADHD Rating Scale-IV

  1 year

• Swanson, Nolan, and Pelham IV scale

  1 year

• Achenbach Child Behavior Checklist

  1 year

• Clinical Global Impressions-ADHD-Severity

  1 year

• Social Adjustment Inventory for Children and Adolescents

  1 year

Study Arms (2)

Patients with ADHD

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

Healthy Controls

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

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Patients with ADHD are eligible to be included in this study only if they meet all of the following criteria:
• Patients will be outpatients who are between 7 and 18 years of age.
• 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).
• Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score \> 4 at baseline.
• Patients must be psychotropic drug-naïve. Patients will be considered to be drug-naïve if they have never received medications specifically to treat ADHD.
• Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.
• 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.
• 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.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• 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.
• Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.
• Patients have been at serious suicidal risk, determined by the investigator.
• 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.
• Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
• Patients who are likely to need Chinese medicine or health-food supplements that have central nervous system activity.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Chi-Yung Shang, MDPHD

  Dept of Psychiatry, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Yung Shang

CONTACT

02-23123456; cyshang@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 3, 2019
• Study Start: April 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 3, 2019

Record last verified: 2018-11

Locations

TW (1)