NCT00211783

Brief Summary

This study investigates face processing, response inhibition and phoneme processing in autistic adults by fMRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

7 years

First QC Date

September 13, 2005

Last Update Submit

June 26, 2012

Conditions

AutismAsperger's Syndrome

Keywords

autismfMRIresponse inhibitionface processinglinguistic processing

Outcome Measures

Primary Outcomes (1)

  • BOLD

    Differences in BOLD betweens controls and ASD group BOLD - blood-oxygen-level-dependent contrast

    at single study visit

Study Arms (2)

Autism

Procedure: fMRI

Control

Interventions

fMRIPROCEDURE

there is no intervention

Autism

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Thirty adults with ASD and 30

You may qualify if:

  • Age range of 18-50 years old
  • Diagnosis: autism spectrum disorder by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) and Autism Diagnostic Interview - Revised (ADI-R)
  • Intelligence quotient (IQ) \> 80
  • Outpatients

You may not qualify if:

  • Subjects with epilepsy
  • Subjects with history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder
  • Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis of Ito, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella
  • Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Autistic DisorderAsperger Syndrome

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Evdokia Anagnostou

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Primary Completion

November 1, 2011

Study Completion

June 1, 2012

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

US(1)