NCT01770548

Brief Summary

Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

Trial Health

87
On Track

Trial Health Score

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

Enrollment
497

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

January 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

January 15, 2013

Last Update Submit

January 13, 2017

Conditions

Autism

Outcome Measures

Primary Outcomes (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

    two years

Study Arms (4)

Autism

EXPERIMENTAL

Analysis of the glutamate synapse in autism

Genetic: analysis of the glutamate synapse in autismGenetic: DNA collectionOther: Auditory evoked potentials

Relative

OTHER

Analysis of the glutamate synapse in autism

Genetic: analysis of the glutamate synapse in autismGenetic: DNA collectionOther: Auditory evoked potentials

Major control

OTHER

DNA collection

Genetic: analysis of the glutamate synapse in autismGenetic: DNA collectionOther: Auditory evoked potentials

Minor control

OTHER

auditory evoked potentials

Other: Auditory evoked potentials

Interventions

analysis of the glutamate synapse in autismGENETIC

Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism

AutismMajor controlRelative
DNA collectionGENETIC

DNA collection

AutismMajor controlRelative
Auditory evoked potentialsOTHER

auditory evoked potentials

AutismMajor controlMinor controlRelative

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • have a Pervasive Developmental Disorder

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHRU - Centre de Ressources Autisme (CRA)

Brest, 29000, France

Location

CHS du ROUVRAY

Rouen, 76000, France

Location

Chru - Cic

Tours, 37000, France

Location

CHRU - Pédopsychiatrie

Tours, F-37000, France

Location

Related Publications (1)

  • Bonnet-Brilhault F, Alirol S, Blanc R, Bazaud S, Marouillat S, Thepault RA, Andres CR, Lemonnier E, Barthelemy 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.

    PMID: 26055424RESULT

MeSH Terms

Conditions

Autistic Disorder

Interventions

Evoked Potentials, Auditory

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Evoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological PhenomenaVestibulocochlear Physiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Frédérique BONNET-BRILHAULT, MD PHD

    University François Rabelais of TOURS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

June 1, 2014

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

FR(4)