NCT00449566

Brief Summary

The purpose of this study is to investigate brain development in autism by longitudinally assessing children with autism, as well as typically developing controls, using advanced MR techniques. We will use longitudinal diffusion tensor imaging (DTI) measures to investigate the protracted development of long-range white matter fibers in autism. In addition, we will investigate the effect of autism risk genes on brain development.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
Last Updated

March 20, 2007

Status Verified

March 1, 2007

First QC Date

March 18, 2007

Last Update Submit

March 18, 2007

Conditions

Autism

Keywords

Magnetic Resonance ImagingDiffusion Tensor Imaging

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 6 - 18 years at initial MRI
  • \) DSM-IV (APA, 1994) diagnosis of autism, according to ADI-R interview
  • no DSM-IV (APA, 1994) diagnosis, according to DISC interview
  • no scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
  • IQ \> 70

You may not qualify if:

  • major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
  • presence of metal objects in or around the body (pacemaker, dental braces)
  • history of or present neurological disorder
  • for individuals over 12 years of age: legal incompetence, defined as the obvious inability to comprehend the information that is presented by the investigator and is outlined in the Information letter and on which the decision to participate in the study is to be based

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Child and Adolescent Psychiatry, UMC Utrecht

Utrecht, 3584CX, Netherlands

RECRUITING

Related Publications (1)

  • Langen M, Durston S, Staal WG, Palmen SJ, van Engeland H. Caudate nucleus is enlarged in high-functioning medication-naive subjects with autism. Biol Psychiatry. 2007 Aug 1;62(3):262-6. doi: 10.1016/j.biopsych.2006.09.040. Epub 2007 Jan 16.

    PMID: 17224135BACKGROUND

Related Links

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sarah Durston, Ph.D.

    Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht

    PRINCIPAL INVESTIGATOR

  • Herman van Engeland, M.D. Ph.D.

    Rudolf Magnust Institute of Neuroscience, UMC Utrecht

    STUDY CHAIR

Central Study Contacts

Sarah Durston

CONTACT

+31 30 250 8161S.Durston@umcutrecht.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2007

First Posted

March 20, 2007

Study Start

January 1, 2006

Last Updated

March 20, 2007

Record last verified: 2007-03

Locations

NL(1)