NCT00755430

Brief Summary

Autism spectrum disorder (ASD) has been given a high priority for genetic and neurobiological study. There is no such information in Asian population and no study has conducted using Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world. Moreover, no follow-up study has been done to examine the developmental changes of structural and functional connectivity. We anticipate to establishing a cohort of 50 ASD and their siblings with complete clinical, neuropsychological, brain imaging, and genetic data for longitudinal study on ASD. Our findings will contribute to our understanding of the structural and functional dysconnectivity for ASD and whether dysconnectivity can be an endophenotype for ASD and used as a biomarker for early diagnosis of ASD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

4 years

First QC Date

September 18, 2008

Last Update Submit

September 1, 2021

Conditions

Keywords

autism spectrum disorders (ASD)structural and functional connectivitydiffusion spectrum imaging (DSI)functional magnetic resonance imaging (fMRI)siblingsrepeated follow-up measurement

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The sample will consist of 50 children with DSM-IV ASD (autistic disorder and Asperger's disorder) aged 3-15, their siblings, and 50 age-, sex-, and handedness-matached healthy controls.

You may qualify if:

  • that subjects have a clinical diagnosis of autistic disorder, or Asperger disorder defined by the DSM-IV and ICD-10, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits;
  • their ages range from 3 to 15 when we conduct the study;
  • subjects and their biological parents (and siblings if any) consent to participate in this study for completing clinical and brain imaging assessments and blood withdraw for genetic study (this criteria also applied to the controls).

You may not qualify if:

  • The proband subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV:
  • Schizophrenia
  • Schizoaffective Disorder
  • Organic Psychosis
  • severe neurological disease. Moreover, the subjects will also be excluded from the study if they completely cannot cooperate with MRI assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

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

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    Dept of Psychiatry, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 19, 2008

Study Start

January 1, 2009

Primary Completion

December 31, 2012

Study Completion

December 31, 2012

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations