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

History of Changes

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:

Drug Information available for: Glutamic Acid Deoxyribonucleic acid

U.S. FDA Resources

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:

Bonnet-Brilhault F, Alirol S, Blanc R, Bazaud S, Marouillat S, Thépault RA, Andres CR, Lemonnier É, Barthélémy C, Raynaud M, Toutain A, Gomot M, Laumonnier F. GABA/Glutamate synaptic pathways targeted by integrative genomic and electrophysiological explorations distinguish autism from intellectual disability. Mol Psychiatry. 2016 Mar;21(3):411-8. doi: 10.1038/mp.2015.75. Epub 2015 Jun 9.


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 30, 2016

To Top