AutismNMDA-AutismNCT01770548
Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism
A study testing analysis of the glutamate synapse in autism, DNA collection and Auditory evoked potentials in people with Autism, run by University Hospital, Tours at 4 sites in France.
Trial summary
Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- analysis of the glutamate synapse in autism, DNA collection and Auditory evoked potentials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 497 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- have a Pervasive Developmental Disorder
Who cannot join
- N/A
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHRU - Centre de Ressources Autisme (CRA)
Brest, 29000
CHS du ROUVRAY
Rouen, 76000
Chru - Cic
Tours, 37000
CHRU - Pédopsychiatrie
Tours, F-37000
About this study
Official title: Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.
Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism
Read the detailed description
Analysis about 50 genes in glutamate synapse
- Conditions
- Autism
- Being tested
- analysis of the glutamate synapse in autism, DNA collection, Auditory evoked potentials
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of the glutamate synapse in autismGenetic
Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism
DNA collectionGenetic
DNA collection
Auditory evoked potentialsOther
auditory evoked potentials
| Study group | Role | What they receive |
|---|---|---|
| Autism | Experimental | Analysis of the glutamate synapse in autism Receives: Genetic: analysis of the glutamate synapse in autism; Genetic: DNA collection; Other: Auditory evoked potentials |
| Relative | Other | Analysis of the glutamate synapse in autism Receives: Genetic: analysis of the glutamate synapse in autism; Genetic: DNA collection; Other: Auditory evoked potentials |
| Major control | Other | DNA collection Receives: Genetic: analysis of the glutamate synapse in autism; Genetic: DNA collection; Other: Auditory evoked potentials |
| Minor control | Other | auditory evoked potentials Receives: Other: Auditory evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérique BONNET-BRILHAULT, MD PHD, Study director, University François Rabelais of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770548
- Sponsor's protocol ID
- AORT08-FBB/NMDA-Autism
- Other IDs
- 2008-A01162-53
- Acronym
- NMDA-Autism
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2013
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26055424
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.
- ClinicalTrials.gov ID
- NCT01770548
- Acronym / sponsor ID
- NMDA-Autism / AORT08-FBB/NMDA-Autism
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism
Detailed description
Analysis about 50 genes in glutamate synapse
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autism | Experimental | Genetic: analysis of the glutamate synapse in autism, Genetic: DNA collection, Other: Auditory evoked potentialsAnalysis of the glutamate synapse in autism |
| Relative | Other | Genetic: analysis of the glutamate synapse in autism, Genetic: DNA collection, Other: Auditory evoked potentialsAnalysis of the glutamate synapse in autism |
| Major control | Other | Genetic: analysis of the glutamate synapse in autism, Genetic: DNA collection, Other: Auditory evoked potentialsDNA collection |
| Minor control | Other | Other: Auditory evoked potentialsauditory evoked potentials |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- have a Pervasive Developmental Disorder
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of the glutamate synapse in autismNeurophysiological, molecular and developmental analysis of the glutamate synapse in autism | Genetic | Autism, Major control, Relative |
| DNA collectionDNA collection | Genetic | Autism, Major control, Relative |
| Auditory evoked potentialsauditory evoked potentials | Other | Autism, Major control, Minor control, Relative |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Results publication: PubMed 26055424Bonnet-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédérique BONNET-BRILHAULT, MD PHD study director
University François Rabelais of TOURS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing analysis of the glutamate synapse in autism, DNA collection and Auditory evoked potentials in people with Autism, run by University Hospital, Tours at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01770548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.