The Metabolome Profiling and Pathway Analysis of ADHD

NCT02942225 | Completed DMC

• 1 other identifier: 201601035RINA
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the pathophysiological mechanisms of ADHD, especially the metabolomic pathway related to the behavioral/neuropsychological deficits of ADHD. To identify specific metabolites that show significant differences between ADHD and control groups, both liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry will be performed. In addition, the behavioral measures include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. Neuropsychological testing, including CPT and CANTAB, will be performed. Conditional logistic regression and partial least squares discriminant analysis will be applied to identify significant metabolites for ADHD. Pathway enrichment and topology analyses will be conducted to evaluate the regulated pathways.

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorder; metabolomics; neuropsychological deficits; pathway analysis

Outcome Measures

Primary Outcomes (1)

• Psychiatric interview

  Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)

  1 hour

Secondary Outcomes (1)

• Spatial working memory

  1.5 hours

Study Arms (2)

ADHD group

Subjects with clinical diagnosis of ADHD according to the DSM-V criteria

TD group

Typically development controls without lifetime diagnosis with ADHD

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We plan to recruit 120 ADHD subjects and 120 control subjects.

You may qualify if:

• Subjects without any current or lifetime DSM-V psychiatric disorders based on the K-SADS-E interviews.

You may not qualify if:

• Participants who had any past or current medical or neurological illness, who currently took psychotropic medication, or whose intelligence quotient (IQ) score was less than 80 were excluded.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will collect blood samples from each participant after 8-hour fasting. Blood samples will be transferred into evacuated tubes that contain anticoagulant sodium dihydrogen phosphate (EDTA), centrifuged at 2000g for 10 minutes at 4°C. Serum will be extracted and stored at -80°C for sample analysis. The collection of blood sample will be conducted at the NTUH.

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, MD

  Dept of Psychiatry, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 24, 2016
• Study Start: August 1, 2016
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)