NCT01582256

Brief Summary

The study aims to investigate whether neuropsychological function (particularly cognitive flexibility and executive function), functional (assessed by resting functional MRI, rfMRI) and structural connectivity (assessed by DSI), and electrophysiological function (assessed by event-related potential \[ERP\]: mismatch negativity, MMN and P50) can be effective cognitive endophenotypes (biomarkers) for Autism spectrum disorders (ASD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2015

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

April 18, 2012

Last Update Submit

September 1, 2021

Conditions

Autism

Study Arms (6)

ASD+CNVs

ASD-CNVs

Unaffected siblings of ASD+CNVs

Unaffected siblings of ASD-CNVs

Neurotypicals for ASD+CNVs comparisons

Neurotypicals for ASD-CNVs comparisons

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample (6 groups) consists of 44 individuals with clinical diagnosis of ASD confirmed by the ADI-R and ADOS assessments (22 with CNVs and 22 without CNVs), their unaffected siblings (n=22 for each group) and age-, sex-, handedness-, and IQ-matched school comparison groups (22 for each group).

You may not qualify if:

  • their ages range from 10 to 25 (because all the probands with CNV aged \> 10);
  • both parents are Han Chinese; and
  • subjects and their parents consent to participate in this study for complete phenotype assessments (3 visits of assessments).
  • if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, or Organic Psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

Related Publications (5)

  • Chien YL, Chen YC, Chiu YN, Tsai WC, Gau SS. A translational exploration of the effects of WNT2 variants on altered cortical structures in autism spectrum disorder. J Psychiatry Neurosci. 2021 Dec 3;46(6):E647-E658. doi: 10.1503/jpn.210022. Print 2021 Nov-Dec.

    PMID: 34862305DERIVED

  • Seng GJ, Tseng WL, Chiu YN, Tsai WC, Wu YY, Gau SS. Executive functions in youths with autism spectrum disorder and their unaffected siblings. Psychol Med. 2021 Nov;51(15):2571-2580. doi: 10.1017/S0033291720001075. Epub 2020 Apr 30.

    PMID: 32349803DERIVED

  • Chien YL, Chou MC, Chiu YN, Chou WJ, Wu YY, Tsai WC, Gau SS. ADHD-related symptoms and attention profiles in the unaffected siblings of probands with autism spectrum disorder: focus on the subtypes of autism and Asperger's disorder. Mol Autism. 2017 Jul 25;8:37. doi: 10.1186/s13229-017-0153-9. eCollection 2017.

    PMID: 28770037DERIVED

  • Chien YL, Tu EN, Gau SS. School Functions in Unaffected Siblings of Youths with Autism Spectrum Disorders. J Autism Dev Disord. 2017 Oct;47(10):3059-3071. doi: 10.1007/s10803-017-3223-0.

    PMID: 28685410DERIVED

  • Chiang HL, Chen YJ, Lin HY, Tseng WI, Gau SS. Disorder-Specific Alteration in White Matter Structural Property in Adults With Autism Spectrum Disorder Relative to Adults With ADHD and Adult Controls. Hum Brain Mapp. 2017 Jan;38(1):384-395. doi: 10.1002/hbm.23367. Epub 2016 Sep 15.

    PMID: 27630075DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The subjects will receive blood withdrawal. The blood sample will be used for establishing lymphoblastoid cell lines, which will be used for molecular genetic experiments.

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    National Taiwan University Hospital & College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Susan Shur-Fen Gau

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 20, 2012

Study Start

August 1, 2012

Primary Completion

July 31, 2015

Study Completion

July 31, 2015

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations

TW(1)