A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With ADHD

Aevi Genomic Medicine

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Study type: Observational

Funder types: Industry

Identifiers

NCT02811211

MDGN-NFC1-ADHD-001

Details and patient eligibility

About

This noninterventional study will assess genomic changes in the metabotropic glutamate receptor (mGluR) network in children and adolescents with ADHD.

Full description

Male and female subjects 6 to 17 years of age with a primary psychiatric diagnosis of ADHD will be enrolled in this study. The subject and his or her parent/guardian must agree to genotyping to determine whether the subject has disruptive mutations within any of the approximately 274 mGluR-network genes, and complete an interview that will include information about the subject's ADHD history, treatment, and co-morbidities.

Enrollment: 1,894 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject is male or female ≥6 and ≤17 years of age.
• The subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
• The subject, his or her legally responsible representative, and investigator agree to complete ADHD history, treatment, and comorbidity electronic case report form (eCRF).

Exclusion criteria

• The subject or parent/legal guardian is in the opinion of the investigator mentally or legally incapacitated and unable to provide informed consent/assent for participation in the study.