Multimodal Neurobiological Approaches to Explore the Gene-Environment Interactions in ADHD

NCT04571125 | Completed

• 1 other identifier: 201912085RINA
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 2

Brief Summary

Previous studies have demonstrated significant associations of attention-deficit hyperactivity disorder (ADHD) with monoamine transporter genes, including dopamine transporter gene (DAT1), norepinephrine transporter gene (SLC6A2), and serotonin transporter gene (SLC6A4) as well as the important role of environmental factors in the pathogenesis of ADHD. Hence, investigating how genes and environments interact with each other may contribute to the understanding of the pathophysiological mechanisms of ADHD. In this 3-year project, investigators will explore the complex gene-environment interplay in ADHD with multimodal neurobiological approaches, including neuropsychology, neuroimaging, and metabolites, in order to identify the crucial pathophysiological pathways from genes to the brain.

Conditions

Monoamine Transporter Genes; Environmental Factors

Outcome Measures

Primary Outcomes (1)

• ADHD symptoms

  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 (4)

• Neuropsychological testing

  1.5 hours

• Neuropsychological testing

  15 mins

• Metabolomics profiling

  10 mins

• Brain imaging

  1 hour

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 - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

120 drug-naïve patients with ADHD, aged 7-16, and 120 age- and sex-matched typically developing controls will be recruited in this project.

You may qualify if:

• Children or adolescents, between 7 and 16 years of age, must have clinical diagnosis of ADHD according to the DSM-5 diagnostic criteria.
• They have to be medication-naïve. They never receive any medication for the treatment of ADHD.
• They and their parents must understand sufficiently to communicate properly with the investigators.
• They must have a Full-Scale Intelligence Quotient(FIQ) score greater than 80.

You may not qualify if:

• They have a major psychiatric comorbid disorder, including schizophrenia, schizoaffective disorder, affective disorders, or autism spectrum disorder.
• They have a past history of seizure, or they are taking antiepileptic drugs.
• They have a past history of substance dependence or abuse, including nicotine, alcohol, amphetamine, or any over-the-counter medication.
• They have a past history of major systemic disease.
• They are using Chinese herbs or health supplements.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 110, Taiwan

Location

college of Medicine, National Taiwan University

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA, plasma

Study Officials

• Susan Shur-Fen Gau, MD, PhD

  Department of Psychiatry, National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 30, 2020
• Study Start: September 19, 2020
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: March 19, 2024

Record last verified: 2023-06

Locations

TW (2)