Status:
RECRUITING
Study of the Genetic Factors Involved in Autism and Related Disorders
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
24-70 years
Brief Summary
The main objective of the study is to define, for Autism Spectrum Disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. For this purpose the ...
Detailed Description
Aim 1: To identify genetic variants in selected synaptic genes, by targeted sequencing with deep coverage of coding regions and a strong focus on previously untested regulatory regions in Autism Spect...
Eligibility Criteria
Inclusion
- Inclusion Criteria---------------------------------------------------------------------------------------------------
- Probands with Autism Spectrum Disorder
- Meet the diagnostic criteria for ASD of the DSM-5 \[American Psychiatric Association, 2013\] based on a consensus between the clinical expertise of expert clinicians, the scores of the Autism Diagnostic Interview-Revised (ADI-R) (Rutter et al, 2003) and those of the Autism Diagnosis Observation Schedule (ADOS-2) (Lord et al, 2012)
- Be at least 24 months (no upper age limit)
- Somatic and Intellectual state compatible with a blood test
- Affiliation to the social insurance
- Signature of informed consent by the applicant or by holders of parental authority if the subject is a minor or by the guardian if the subject is under guardianship
- Controls without ASD
- At least 24 months old
- Somatic and Intellectual state compatible with a blood test
- Affiliation to the social insurance
- Signature of informed consent by the subject or by holders of parental authority if the subject is a minor or by the guardian if the subject is under guardianship
- Relatives of the probands with ASD or of controls without ASD
- At least 24 months old
- Somatic and Intellectual state compatible with a blood test
- Affiliation to the social insurance
- Signature of informed consent by the subject or by holders of parental authority if the subject is a minor or by the guardian if the subject is under guardianship
- Exclusion Criteria --------------------------------------------------------------------------------------------------
- Probands with Autism Spectrum Disorder
- Severe Intelectual Deficiency (IQ,35 or developmental age \<18 months)
- ●. Personal psychiatric history (schizophrenia, bipolar disorder, substance use disorder (except tobacco), recurrent depression disorder, severe instable anxiety disorder)
- Personal neurologic history (epilepsy, or severe neurological disease)
- Relatives of the probands with ASD, of the controls or the controls:
- ● Medical condition (psychiatric or somatic) not compatible with the inclusion
Exclusion
Key Trial Info
Start Date :
March 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2036
Estimated Enrollment :
3800 Patients enrolled
Trial Details
Trial ID
NCT04727489
Start Date
March 30 2021
End Date
March 1 2036
Last Update
December 23 2025
Active Locations (6)
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1
Centre de rehabilitation psychosociale, Hopital Saint Egreve
Grenoble, Grenoble, France
2
CIC, CHU Bordeaux
Bordeaux, France
3
CRA, Hopital Charles Perrens, Bordeaux
Bordeaux, France
4
CIC, H. Mondor, Creteil
Créteil, France