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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01770548
First received: January 15, 2013
Last updated: July 29, 2016
Last verified: July 2016
  Purpose
Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

Condition Intervention
Autism
Genetic: analysis of the glutamate synapse in autism
Genetic: DNA collection
Other: Auditory evoked potentials

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 497
Study Start Date: January 2009
Study Completion Date: June 2014
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Analysis about 50 genes in glutamate synapse
  Eligibility

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

Inclusion Criteria:

  • have a Pervasive Developmental Disorder

Exclusion Criteria:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01770548     History of Changes
Other Study ID Numbers: AORT08-FBB/NMDA-Autism  2008-A01162-53 
Study First Received: January 15, 2013
Last Updated: July 29, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 29, 2016