ClinicalTrials.gov
ClinicalTrials.gov Menu

Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism (NMDA-Autism)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01770548
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

Condition or disease Intervention/treatment Phase
Autism Genetic: analysis of the glutamate synapse in autism Genetic: DNA collection Other: Auditory evoked potentials Not Applicable

Detailed Description:
Analysis about 50 genes in glutamate synapse

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 497 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.
Study Start Date : January 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : June 2014
Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Autism
Analysis of the glutamate synapse in autism
 Genetic: analysis of the glutamate synapse in autism
Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism
Genetic: DNA collection
DNA collection
Other: Auditory evoked potentials
auditory evoked potentials
Relative
Analysis of the glutamate synapse in autism
 Genetic: analysis of the glutamate synapse in autism
Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism
Genetic: DNA collection
DNA collection
Other: Auditory evoked potentials
auditory evoked potentials
Major control
DNA collection
 Genetic: analysis of the glutamate synapse in autism
Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism
Genetic: DNA collection
DNA collection
Other: Auditory evoked potentials
auditory evoked potentials
Minor control
auditory evoked potentials
 Other: Auditory evoked potentials
auditory evoked potentials


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. screening of about 50 genes encoding proteins of the NMDA receptor complex, chosen according to their chromosomal localisation located in hotspots depicted by genome-wide screens in large population of autistic patients [ Time Frame: two years ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • have a Pervasive Developmental Disorder

Exclusion Criteria:

Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770548


Locations
France
CHRU - Centre de Ressources Autisme (CRA)
Brest, France, 29000
CHS du ROUVRAY
Rouen, France, 76000
Chru - Cic
Tours, France, 37000
CHRU - Pédopsychiatrie
Tours, France, F-37000
Sponsors and Collaborators
University Hospital, Tours
Investigators
Study Director: Frédérique BONNET-BRILHAULT, MD PHD University François Rabelais of TOURS
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01770548     History of Changes
Other Study ID Numbers: AORT08-FBB/NMDA-Autism
2008-A01162-53 ( Other Identifier: ID RCB )
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders